Trial Outcomes & Findings for A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED) (NCT NCT00250432)
NCT ID: NCT00250432
Last Updated: 2017-03-24
Results Overview
Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
204 participants
Primary outcome timeframe
90 Days
Results posted on
2017-03-24
Participant Flow
This was a Phase III study. The first patient was enrolled (FPE) on 13-Jan-2006. The last patient's last visit (LPLV) was on 13-Mar-2008. A total of 38 inpatient centers were involved in the recruitment worldwide (14 in the United States, 13 in the European Union, 7 in Central or South America, and 4 in Asia)
Participant milestones
| Measure |
Caspofungin 70/50 mg
Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
|
Caspofungin 150 mg
Caspofungin 150 mg IV daily
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
100
|
|
Overall Study
COMPLETED
|
59
|
53
|
|
Overall Study
NOT COMPLETED
|
45
|
47
|
Reasons for withdrawal
| Measure |
Caspofungin 70/50 mg
Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
|
Caspofungin 150 mg
Caspofungin 150 mg IV daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
25
|
29
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
|
Overall Study
Patient Moved
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
|
Overall Study
Pt died out of posttherapy report period
|
6
|
5
|
|
Overall Study
Pt was considered untreatable
|
0
|
1
|
Baseline Characteristics
A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Caspofungin 70/50 mg
n=104 Participants
Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
|
Caspofungin 150 mg
n=100 Participants
Caspofungin 150 mg IV daily
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 years
n=5 Participants
|
57.8 years
n=7 Participants
|
56.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
70 participants
n=5 Participants
|
65 participants
n=7 Participants
|
135 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Site Of Invasive Candida Infection
Abscess(involving an intra-abdominal site)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Site Of Invasive Candida Infection
Abscess (involving a non-abdominal site)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Site Of Invasive Candida Infection
Acute disseminated candidiasis or multiple sites
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Site Of Invasive Candida Infection
Blood (candidemia)
|
91 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Site Of Invasive Candida Infection
Chronic disseminated candidiasis (hepatosplenic)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Site Of Invasive Candida Infection
Fungemia (non Candida)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Site Of Invasive Candida Infection
Kidney (Pyelonephritis)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Site Of Invasive Candida Infection
Lung (Pneumonia)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Site Of Invasive Candida Infection
Peritoneal fluid (Peritonitis)
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Site Of Invasive Candida Infection
Pleural fluid (Empyema)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
APACHE II Score (at Study Entry)
|
16.5 Units on a Scale
n=5 Participants
|
17.0 Units on a Scale
n=7 Participants
|
16.8 Units on a Scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 DaysPopulation: All patients as treated population
Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.
Outcome measures
| Measure |
Caspofungin 70/50 mg
n=104 Participants
Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
|
Caspofungin 150 mg
n=100 Participants
Caspofungin 150 mg IV daily
|
|---|---|---|
|
Number of Patients Who Develop Significant Drug-related Adverse Events.
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 90 DaysPopulation: Full Analysis Set (FAS): Included those patients who received at least 1 full dose of caspofungin study therapy and had a documented diagnosis of invasive candidiasis from a sterile, invasive body site, as defined in the protocol.
Number of patients with a favorable overall response, defined as a clinical response of "cure" or "apparent cure" along with a microbiological response of "eradication" or "presumptive eradication" at the End of Caspofungin Therapy.
Outcome measures
| Measure |
Caspofungin 70/50 mg
n=102 Participants
Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
|
Caspofungin 150 mg
n=95 Participants
Caspofungin 150 mg IV daily
|
|---|---|---|
|
Number of Patients With a Favorable Overall Response.
|
73 Participants
|
74 Participants
|
Adverse Events
Caspofungin 70/50 mg
Serious events: 46 serious events
Other events: 69 other events
Deaths: 0 deaths
Caspofungin 150 mg
Serious events: 44 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caspofungin 70/50 mg
Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
|
Caspofungin 150 mg
Caspofungin 150 mg IV daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/104
|
1.0%
1/100
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.96%
1/104
|
0.00%
0/100
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/104
|
1.0%
1/100
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/104
|
1.0%
1/100
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.96%
1/104
|
0.00%
0/100
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/104
|
1.0%
1/100
|
|
Cardiac disorders
Cardiac Arrest
|
0.96%
1/104
|
1.0%
1/100
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/104
|
1.0%
1/100
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
1.9%
2/104
|
0.00%
0/100
|
|
Cardiac disorders
Electromechanical Disorder
|
0.96%
1/104
|
0.00%
0/100
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.96%
1/104
|
1.0%
1/100
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer Perforation
|
0.00%
0/104
|
1.0%
1/100
|
|
Gastrointestinal disorders
Haematemesis
|
0.96%
1/104
|
0.00%
0/100
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/104
|
1.0%
1/100
|
|
Gastrointestinal disorders
Intra-Abdominal Haemorrhage
|
0.00%
0/104
|
1.0%
1/100
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.96%
1/104
|
0.00%
0/100
|
|
Gastrointestinal disorders
Peritoneal Haemorrhage
|
0.00%
0/104
|
1.0%
1/100
|
|
Gastrointestinal disorders
Vomiting
|
0.96%
1/104
|
0.00%
0/100
|
|
General disorders
Brain Death
|
0.96%
1/104
|
0.00%
0/100
|
|
General disorders
Death
|
1.9%
2/104
|
0.00%
0/100
|
|
General disorders
General Physical Health Deterioration
|
0.96%
1/104
|
0.00%
0/100
|
|
General disorders
Multi-Organ Failure
|
4.8%
5/104
|
4.0%
4/100
|
|
General disorders
Non-Cardiac Chest Pain
|
0.96%
1/104
|
0.00%
0/100
|
|
General disorders
Pyrexia
|
0.96%
1/104
|
0.00%
0/100
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.00%
0/104
|
1.0%
1/100
|
|
Hepatobiliary disorders
Hepatitis Toxic
|
0.00%
0/104
|
1.0%
1/100
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/104
|
1.0%
1/100
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.96%
1/104
|
0.00%
0/100
|
|
Infections and infestations
Abdominal Sepsis
|
0.00%
0/104
|
2.0%
2/100
|
|
Infections and infestations
Bacteraemia
|
1.9%
2/104
|
0.00%
0/100
|
|
Infections and infestations
Cellulitis
|
1.9%
2/104
|
0.00%
0/100
|
|
Infections and infestations
Cholecystitis Infective
|
0.00%
0/104
|
1.0%
1/100
|
|
Infections and infestations
Clostridial Infection
|
0.96%
1/104
|
0.00%
0/100
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.00%
0/104
|
2.0%
2/100
|
|
Infections and infestations
Fungaemia
|
1.9%
2/104
|
0.00%
0/100
|
|
Infections and infestations
Fungal Sepsis
|
0.00%
0/104
|
1.0%
1/100
|
|
Infections and infestations
Klebsiella Bacteraemia
|
0.00%
0/104
|
1.0%
1/100
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/104
|
1.0%
1/100
|
|
Infections and infestations
Meningitis Aseptic
|
0.96%
1/104
|
0.00%
0/100
|
|
Infections and infestations
Pneumonia
|
2.9%
3/104
|
4.0%
4/100
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.96%
1/104
|
0.00%
0/100
|
|
Infections and infestations
Pseudomonal Bacteraemia
|
0.00%
0/104
|
1.0%
1/100
|
|
Infections and infestations
Sepsis
|
4.8%
5/104
|
6.0%
6/100
|
|
Infections and infestations
Septic Shock
|
11.5%
12/104
|
13.0%
13/100
|
|
Infections and infestations
Stenotrophomonas Infection
|
0.00%
0/104
|
1.0%
1/100
|
|
Infections and infestations
Systemic Candida
|
0.96%
1/104
|
1.0%
1/100
|
|
Infections and infestations
Urosepsis
|
0.00%
0/104
|
1.0%
1/100
|
|
Infections and infestations
Wound Infection
|
0.96%
1/104
|
0.00%
0/100
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/104
|
1.0%
1/100
|
|
Injury, poisoning and procedural complications
Tracheal Obstruction
|
0.00%
0/104
|
1.0%
1/100
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/104
|
1.0%
1/100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/104
|
1.0%
1/100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Myeloid Leukaemia
|
0.96%
1/104
|
0.00%
0/100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.00%
0/104
|
1.0%
1/100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lung
|
0.96%
1/104
|
0.00%
0/100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary Cancer Metastatic
|
0.96%
1/104
|
0.00%
0/100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Necrosis
|
0.96%
1/104
|
0.00%
0/100
|
|
Nervous system disorders
Cerebral Haematoma
|
0.96%
1/104
|
0.00%
0/100
|
|
Nervous system disorders
Convulsion
|
1.9%
2/104
|
0.00%
0/100
|
|
Nervous system disorders
Myasthenia Gravis
|
0.00%
0/104
|
1.0%
1/100
|
|
Nervous system disorders
Partial Seizures
|
0.00%
0/104
|
1.0%
1/100
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/104
|
1.0%
1/100
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.9%
2/104
|
2.0%
2/100
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.96%
1/104
|
0.00%
0/100
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.9%
2/104
|
3.0%
3/100
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.96%
1/104
|
1.0%
1/100
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.96%
1/104
|
0.00%
0/100
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/104
|
1.0%
1/100
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/104
|
1.0%
1/100
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.96%
1/104
|
0.00%
0/100
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.96%
1/104
|
1.0%
1/100
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/104
|
1.0%
1/100
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
1.9%
2/104
|
1.0%
1/100
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.00%
0/104
|
1.0%
1/100
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.8%
6/104
|
1.0%
1/100
|
|
Vascular disorders
Haemodynamic Instability
|
0.00%
0/104
|
1.0%
1/100
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.00%
0/104
|
1.0%
1/100
|
|
Vascular disorders
Shock Haemorrhage
|
0.00%
0/104
|
1.0%
1/100
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.96%
1/104
|
0.00%
0/100
|
Other adverse events
| Measure |
Caspofungin 70/50 mg
Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
|
Caspofungin 150 mg
Caspofungin 150 mg IV daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
3/104
|
4.0%
4/100
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/104
|
3.0%
3/100
|
|
Cardiac disorders
Bradycardia
|
1.9%
2/104
|
2.0%
2/100
|
|
Cardiac disorders
Tachycardia
|
0.96%
1/104
|
2.0%
2/100
|
|
Cardiac disorders
Ventricular Tachycardia
|
2.9%
3/104
|
2.0%
2/100
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/104
|
2.0%
2/100
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
3/104
|
0.00%
0/100
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.9%
2/104
|
3.0%
3/100
|
|
Gastrointestinal disorders
Constipation
|
2.9%
3/104
|
3.0%
3/100
|
|
Gastrointestinal disorders
Diarrhea
|
5.8%
6/104
|
7.0%
7/100
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.96%
1/104
|
2.0%
2/100
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/104
|
2.0%
2/100
|
|
Gastrointestinal disorders
Ileus
|
2.9%
3/104
|
1.0%
1/100
|
|
Gastrointestinal disorders
Nausea
|
4.8%
5/104
|
7.0%
7/100
|
|
Gastrointestinal disorders
Vomiting
|
9.6%
10/104
|
6.0%
6/100
|
|
General disorders
Asthenia
|
1.9%
2/104
|
3.0%
3/100
|
|
General disorders
Chest Pain
|
0.96%
1/104
|
2.0%
2/100
|
|
General disorders
Generalised Oedema
|
2.9%
3/104
|
0.00%
0/100
|
|
General disorders
Hypothermia
|
1.9%
2/104
|
2.0%
2/100
|
|
General disorders
Injection Site Erythema
|
0.00%
0/104
|
2.0%
2/100
|
|
General disorders
Injection Site Phlebitis
|
3.8%
4/104
|
2.0%
2/100
|
|
General disorders
Injection Site Swelling
|
0.96%
1/104
|
2.0%
2/100
|
|
General disorders
Oedema
|
0.96%
1/104
|
2.0%
2/100
|
|
General disorders
Oedema Peripheral
|
3.8%
4/104
|
2.0%
2/100
|
|
General disorders
Pyrexia
|
4.8%
5/104
|
6.0%
6/100
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/104
|
2.0%
2/100
|
|
Infections and infestations
Bacteraemia
|
2.9%
3/104
|
2.0%
2/100
|
|
Infections and infestations
Empyema
|
0.96%
1/104
|
2.0%
2/100
|
|
Infections and infestations
Pneumonia
|
1.9%
2/104
|
4.0%
4/100
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
2.9%
3/104
|
4.0%
4/100
|
|
Infections and infestations
Urinary Tract Infection
|
2.9%
3/104
|
2.0%
2/100
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/104
|
2.0%
2/100
|
|
Investigations
Alanine Aminotransferase Increased
|
3.8%
4/104
|
7.0%
7/100
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.8%
6/104
|
9.0%
9/100
|
|
Investigations
Blood Albumin Decreased
|
1.9%
2/104
|
2.0%
2/100
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
11.5%
12/104
|
9.0%
9/100
|
|
Investigations
Blood Bilirubin Increased
|
2.9%
3/104
|
2.0%
2/100
|
|
Investigations
Blood Calcium Decreased
|
0.96%
1/104
|
2.0%
2/100
|
|
Investigations
Blood Calcium Increased
|
0.00%
0/104
|
2.0%
2/100
|
|
Investigations
Blood Chloride Increased
|
0.00%
0/104
|
3.0%
3/100
|
|
Investigations
Blood Creatinine Increased
|
2.9%
3/104
|
3.0%
3/100
|
|
Investigations
Blood Glucose Decreased
|
2.9%
3/104
|
1.0%
1/100
|
|
Investigations
Blood Glucose Increased
|
0.96%
1/104
|
3.0%
3/100
|
|
Investigations
Blood Magnesium Decreased
|
3.8%
4/104
|
4.0%
4/100
|
|
Investigations
Blood Phosphorus Decreased
|
1.9%
2/104
|
2.0%
2/100
|
|
Investigations
Blood Potassium Decreased
|
5.8%
6/104
|
8.0%
8/100
|
|
Investigations
Blood Potassium Increased
|
1.9%
2/104
|
4.0%
4/100
|
|
Investigations
Blood Sodium Decreased
|
0.96%
1/104
|
3.0%
3/100
|
|
Investigations
Blood Sodium Increased
|
1.9%
2/104
|
4.0%
4/100
|
|
Investigations
Blood Urea Increased
|
3.8%
4/104
|
1.0%
1/100
|
|
Investigations
Blood Uric Acid Decreased
|
0.00%
0/104
|
2.0%
2/100
|
|
Investigations
Carbon Dioxide Decreased
|
0.00%
0/104
|
2.0%
2/100
|
|
Investigations
White Blood Cell Count Increased
|
0.96%
1/104
|
3.0%
3/100
|
|
Investigations
Hyperglycaemia
|
1.9%
2/104
|
3.0%
3/100
|
|
Investigations
Hypoglycaemia
|
0.96%
1/104
|
3.0%
3/100
|
|
Investigations
Hypokalaemia
|
1.9%
2/104
|
2.0%
2/100
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.96%
1/104
|
3.0%
3/100
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.96%
1/104
|
2.0%
2/100
|
|
Nervous system disorders
Convulsion
|
2.9%
3/104
|
0.00%
0/100
|
|
Nervous system disorders
Headache
|
4.8%
5/104
|
4.0%
4/100
|
|
Psychiatric disorders
Agitation
|
2.9%
3/104
|
3.0%
3/100
|
|
Psychiatric disorders
Confusional State
|
2.9%
3/104
|
2.0%
2/100
|
|
Psychiatric disorders
Delirium
|
0.00%
0/104
|
2.0%
2/100
|
|
Psychiatric disorders
Depression
|
2.9%
3/104
|
1.0%
1/100
|
|
Psychiatric disorders
Insomnia
|
2.9%
3/104
|
1.0%
1/100
|
|
Renal and urinary disorders
Renal Failure
|
2.9%
3/104
|
2.0%
2/100
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/104
|
2.0%
2/100
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
2.9%
3/104
|
1.0%
1/100
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.96%
1/104
|
2.0%
2/100
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
4/104
|
3.0%
3/100
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/104
|
2.0%
2/100
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.9%
2/104
|
2.0%
2/100
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/104
|
2.0%
2/100
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/104
|
2.0%
2/100
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
2.9%
3/104
|
1.0%
1/100
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
2.9%
3/104
|
5.0%
5/100
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/104
|
3.0%
3/100
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
5/104
|
3.0%
3/100
|
|
Vascular disorders
Haematoma
|
2.9%
3/104
|
0.00%
0/100
|
|
Vascular disorders
Hypertension
|
4.8%
5/104
|
6.0%
6/100
|
|
Vascular disorders
Hypotension
|
6.7%
7/104
|
3.0%
3/100
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.00%
0/104
|
2.0%
2/100
|
|
Vascular disorders
Phlebitis
|
2.9%
3/104
|
1.0%
1/100
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.00%
0/104
|
3.0%
3/100
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER