Trial Outcomes & Findings for Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100) (NCT NCT00686829)
NCT ID: NCT00686829
Last Updated: 2020-12-03
Results Overview
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Results posted on
2020-12-03
Participant Flow
Participants with human immunodeficiency virus (HIV) infection enrolled in AIDS Clinical Trial Group (ACTG) study A5211 (NCT00082498) and (1) completed the 48-week phase, or (2) had detectable alpha-chemokine receptor 4 (CXCR4)-tropic virus but maintained a virologic response and no drop in cluster of differentiation 4 (CD4)/CD8 count from baseline, or (3) met all inclusion/exclusion criteria but were unable to enroll in ACTG A5211 due to protocol closure prior to their randomization and dosing.
Participant milestones
| Measure |
VCV 30 mg
Participants took VCV 30 mg once daily.
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
VCV 30 mg
Participants took VCV 30 mg once daily.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Sponsor discontinued VCV
|
47
|
Baseline Characteristics
Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)
Baseline characteristics by cohort
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Age, Continuous
|
49 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)Population: All treated participants are included.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
Outcome measures
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Percentage of Participants With ≥1 Adverse Events (AEs)
|
91 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)Population: All treated participants are included.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
Outcome measures
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Percentage of Participants Discontinuing Study Therapy Due to AEs
|
6 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)Population: All treated participants are included.
An SAE is any adverse occurrence that results in death; is life-threatening; results in a persistent disability; requires in-patient hospitalization or prolongs hospitalization; or is a congenital anomaly/birth defect.
Outcome measures
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
|
48 Percentage of Participants
|
PRIMARY outcome
Timeframe: Every 12 months up to 60 monthsPopulation: All treated participants with HIV RNA data available are included.
The percentage of participants with HIV RNA \<50 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Outcome measures
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
Month 12
|
52 Percentage of Participants
|
|
Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
Month 24
|
64 Percentage of Participants
|
|
Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
Month 36
|
80 Percentage of Participants
|
|
Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
Month 48
|
89 Percentage of Participants
|
|
Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
Month 60
|
80 Percentage of Participants
|
PRIMARY outcome
Timeframe: Every 12 months up to 60 monthsPopulation: All treated participants with HIV RNA data available are included.
The percentage of participants with HIV RNA \>50 to \<400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Outcome measures
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Percentage of Participants With HIV RNA >50 to <400 Copies/mL
Month 12
|
13 Percentage of Participants
|
|
Percentage of Participants With HIV RNA >50 to <400 Copies/mL
Month 24
|
11 Percentage of Participants
|
|
Percentage of Participants With HIV RNA >50 to <400 Copies/mL
Month 36
|
12 Percentage of Participants
|
|
Percentage of Participants With HIV RNA >50 to <400 Copies/mL
Month 48
|
2 Percentage of Participants
|
|
Percentage of Participants With HIV RNA >50 to <400 Copies/mL
Month 60
|
15 Percentage of Participants
|
PRIMARY outcome
Timeframe: Every 12 months up to 60 monthsPopulation: All treated participants with HIV RNA data available are included.
The percentage of participants with HIV RNA ≥400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Outcome measures
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Percentage of Participants With HIV RNA ≥400 Copies/mL
Month 12
|
35 Percentage of Participants
|
|
Percentage of Participants With HIV RNA ≥400 Copies/mL
Month 24
|
25 Percentage of Participants
|
|
Percentage of Participants With HIV RNA ≥400 Copies/mL
Month 36
|
8 Percentage of Participants
|
|
Percentage of Participants With HIV RNA ≥400 Copies/mL
Month 48
|
9 Percentage of Participants
|
|
Percentage of Participants With HIV RNA ≥400 Copies/mL
Month 60
|
5 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 yearsPopulation: All treated participants with baseline and VF tropism data available are included.
The number of participants with non reportable (NR) tropism, CCR5 (R5) tropism, or dual/mixed CCR5/CXCR4 (DM/X4) tropism at baseline, who had NR, R5, or DM/X4 tropism at the time of virologic failure (VF) is reported. The definition of VF is an increase in HIV RNA level \>0.5 log10 copies/mL compared to the baseline HIV RNA level.
Outcome measures
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Number of Participants With Coreceptor Tropism Shifts From Baseline
NR Baseline to NR VF
|
45 Participants
|
|
Number of Participants With Coreceptor Tropism Shifts From Baseline
NR at Baseline to R5 VF
|
10 Participants
|
|
Number of Participants With Coreceptor Tropism Shifts From Baseline
NR Baseline to DM/X4 VF
|
5 Participants
|
|
Number of Participants With Coreceptor Tropism Shifts From Baseline
R5 baseline to R5 VF
|
11 Participants
|
|
Number of Participants With Coreceptor Tropism Shifts From Baseline
R5 baseline to NR VF
|
3 Participants
|
|
Number of Participants With Coreceptor Tropism Shifts From Baseline
R5 baseline to DM/X4 VF
|
1 Participants
|
|
Number of Participants With Coreceptor Tropism Shifts From Baseline
DM/X4 baseline to DM/X4 VF
|
3 Participants
|
|
Number of Participants With Coreceptor Tropism Shifts From Baseline
DM/X4 baseline to R5 VF
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 yearsPopulation: All treated participants with baseline and on-treatment CD4/CD8 data available are included.
The mean change from baseline in CD4/CD8 counts throughout P4100 until the time of VF is reported. "Month" was defined as each 28-day period on study treatment. A fluorescent-activated cell sorter (FACS) analysis was used to quantify CD4/CD8 lymphocytes. The definition of VF is an increase in HIV RNA level \>0.5 log10 copies/mL compared to the baseline HIV RNA level.
Outcome measures
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 2
|
-16.26 cells/mm^3
Standard Deviation 103.83
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 4
|
-17.70 cells/mm^3
Standard Deviation 84.87
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 6
|
9.30 cells/mm^3
Standard Deviation 95.38
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 8
|
-0.20 cells/mm^3
Standard Deviation 115.96
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 10
|
12.59 cells/mm^3
Standard Deviation 97.84
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 12
|
-13.81 cells/mm^3
Standard Deviation 124.09
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 14
|
18.56 cells/mm^3
Standard Deviation 106.18
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 16
|
21.63 cells/mm^3
Standard Deviation 130.33
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 18
|
2.82 cells/mm^3
Standard Deviation 108.52
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 20
|
19.71 cells/mm^3
Standard Deviation 125.34
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 22
|
24.19 cells/mm^3
Standard Deviation 94.37
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 24
|
32.04 cells/mm^3
Standard Deviation 121.45
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 26
|
34.36 cells/mm^3
Standard Deviation 128.99
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 28
|
36.10 cells/mm^3
Standard Deviation 120.75
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 30
|
38.10 cells/mm^3
Standard Deviation 113.80
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 32
|
47.59 cells/mm^3
Standard Deviation 137.15
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 34
|
61.93 cells/mm^3
Standard Deviation 109.71
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 36
|
43.63 cells/mm^3
Standard Deviation 136.85
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 38
|
90.81 cells/mm^3
Standard Deviation 140.11
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 40
|
75.53 cells/mm^3
Standard Deviation 142.90
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 42
|
104.65 cells/mm^3
Standard Deviation 187.14
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 44
|
91.61 cells/mm^3
Standard Deviation 181.71
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 46
|
91.19 cells/mm^3
Standard Deviation 165.33
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 48
|
93.93 cells/mm^3
Standard Deviation 174.36
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 50
|
128.12 cells/mm^3
Standard Deviation 189.94
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 52
|
107.41 cells/mm^3
Standard Deviation 170.97
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 54
|
136.00 cells/mm^3
Standard Deviation 211.98
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 56
|
129.87 cells/mm^3
Standard Deviation 196.80
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 58
|
188.81 cells/mm^3
Standard Deviation 152.93
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 60
|
122.60 cells/mm^3
Standard Deviation 191.32
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 62
|
132.54 cells/mm^3
Standard Deviation 118.87
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 64
|
147.50 cells/mm^3
Standard Deviation 197.12
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 66
|
283.50 cells/mm^3
Standard Deviation 2.12
|
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Month 68
|
300.00 cells/mm^3
Standard Deviation 50.91
|
PRIMARY outcome
Timeframe: Up to time of VF in P4100, assessed up to approximately 5.5 yearsPopulation: All treated participants are included.
The total number of participants with viruses having phenotypic resistance to VCV is reported. Viruses exhibiting both maximum percent inhibition (MPI) plateau values of \<85% and relative MPI (R-MPI) values of \<0.9 (based on the PhenoSense HIV entry assay) were considered to have phenotypic resistance to VCV.
Outcome measures
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Number of Participants With Reduced Susceptibility to VCV
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)Population: All treated participants are included.
The number of participants with ADEs is reported. An ADE is an SAE that is expected in the course of disease and not considered related to study intervention. The sponsor identified events that met ADE criteria based on the 1993 Centers for Disease Control (CDC) Revised Classification System.
Outcome measures
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Number of Participants With AIDS-defining Events (ADEs)
Plasmablastic Lymphoma
|
1 Participants
|
|
Number of Participants With AIDS-defining Events (ADEs)
Kaposi's Sarcoma
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)Population: All treated participants are included.
The number of participants with new infections is reported.
Outcome measures
| Measure |
VCV 30 mg
n=79 Participants
Participants took VCV 30 mg once daily.
|
|---|---|
|
Number of Participants With New Infections
Herpes simplex virus infection
|
6 Participants
|
|
Number of Participants With New Infections
Upper respiratory tract infection
|
39 Participants
|
Adverse Events
VCV 30 mg
Serious events: 38 serious events
Other events: 70 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
VCV 30 mg
n=79 participants at risk
Participants took VCV 30 mg once daily.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Cardiac disorders
ARRHYTHMIA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.3%
1/79 • Number of events 2 • Up to approximately 5.5 years
All treated participants are included.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
3.8%
3/79 • Number of events 3 • Up to approximately 5.5 years
All treated participants are included.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Cardiac disorders
PERICARDITIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Eye disorders
EYELID PTOSIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Eye disorders
GLAUCOMA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Eye disorders
OPTIC ISCHAEMIC NEUROPATHY
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Eye disorders
RETINAL VEIN OCCLUSION
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.5%
2/79 • Number of events 2 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
NAUSEA
|
2.5%
2/79 • Number of events 2 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
OESOPHAGEAL HAEMORRHAGE
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
PANCREATITIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMATOMA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
SWOLLEN TONGUE
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
VOMITING
|
2.5%
2/79 • Number of events 3 • Up to approximately 5.5 years
All treated participants are included.
|
|
General disorders
ASTHENIA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
General disorders
CHEST PAIN
|
3.8%
3/79 • Number of events 3 • Up to approximately 5.5 years
All treated participants are included.
|
|
General disorders
CHILLS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
General disorders
PYREXIA
|
3.8%
3/79 • Number of events 3 • Up to approximately 5.5 years
All treated participants are included.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Immune system disorders
ALLERGY TO VACCINE
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
ANOGENITAL WARTS
|
2.5%
2/79 • Number of events 2 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
BACTERAEMIA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
BRONCHITIS
|
1.3%
1/79 • Number of events 2 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
CELLULITIS
|
3.8%
3/79 • Number of events 3 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
ENDOCARDITIS BACTERIAL
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
MENINGITIS COCCIDIOIDES
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
OSTEOMYELITIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
PNEUMONIA
|
6.3%
5/79 • Number of events 5 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
PYELONEPHRITIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
SEPSIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
STAPHYLOCOCCAL ABSCESS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
VIRAL PERICARDITIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
BLOOD AMYLASE INCREASED
|
3.8%
3/79 • Number of events 3 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
1.3%
1/79 • Number of events 2 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
LIPASE INCREASED
|
2.5%
2/79 • Number of events 2 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
2.5%
2/79 • Number of events 2 • Up to approximately 5.5 years
All treated participants are included.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
AXILLARY MASS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINAL STENOSIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAL CANCER
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HODGKIN'S DISEASE
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC SQUAMOUS CELL CARCINOMA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Nervous system disorders
HEADACHE
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Nervous system disorders
MUSCLE CONTRACTIONS INVOLUNTARY
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Nervous system disorders
PARAESTHESIA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.5%
2/79 • Number of events 2 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
6.3%
5/79 • Number of events 7 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Surgical and medical procedures
CARDIAC PACEMAKER REVISION
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Surgical and medical procedures
COLOSTOMY
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Surgical and medical procedures
HIP ARTHROPLASTY
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Surgical and medical procedures
HYSTERECTOMY
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Surgical and medical procedures
LAMINAPLASTY
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Surgical and medical procedures
LARGE INTESTINE ANASTOMOSIS
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Surgical and medical procedures
OESOPHAGOGASTRIC FUNDOPLASTY
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Surgical and medical procedures
SIGMOIDECTOMY
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Vascular disorders
EMBOLISM ARTERIAL
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
|
Vascular disorders
HAEMATOMA
|
1.3%
1/79 • Number of events 1 • Up to approximately 5.5 years
All treated participants are included.
|
Other adverse events
| Measure |
VCV 30 mg
n=79 participants at risk
Participants took VCV 30 mg once daily.
|
|---|---|
|
Vascular disorders
HYPERTENSION
|
13.9%
11/79 • Number of events 11 • Up to approximately 5.5 years
All treated participants are included.
|
|
Ear and labyrinth disorders
EAR CONGESTION
|
5.1%
4/79 • Number of events 4 • Up to approximately 5.5 years
All treated participants are included.
|
|
Eye disorders
EYE PAIN
|
5.1%
4/79 • Number of events 5 • Up to approximately 5.5 years
All treated participants are included.
|
|
Eye disorders
EYE PRURITUS
|
5.1%
4/79 • Number of events 4 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
11.4%
9/79 • Number of events 15 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
13.9%
11/79 • Number of events 18 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.9%
7/79 • Number of events 10 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
CONSTIPATION
|
11.4%
9/79 • Number of events 13 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
DIARRHOEA
|
32.9%
26/79 • Number of events 44 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.3%
5/79 • Number of events 6 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
FLATULENCE
|
6.3%
5/79 • Number of events 5 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
11.4%
9/79 • Number of events 10 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
5.1%
4/79 • Number of events 4 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
NAUSEA
|
35.4%
28/79 • Number of events 43 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
TOOTHACHE
|
6.3%
5/79 • Number of events 8 • Up to approximately 5.5 years
All treated participants are included.
|
|
Gastrointestinal disorders
VOMITING
|
13.9%
11/79 • Number of events 17 • Up to approximately 5.5 years
All treated participants are included.
|
|
General disorders
CHEST DISCOMFORT
|
5.1%
4/79 • Number of events 4 • Up to approximately 5.5 years
All treated participants are included.
|
|
General disorders
CHEST PAIN
|
6.3%
5/79 • Number of events 9 • Up to approximately 5.5 years
All treated participants are included.
|
|
General disorders
CHILLS
|
10.1%
8/79 • Number of events 11 • Up to approximately 5.5 years
All treated participants are included.
|
|
General disorders
FATIGUE
|
36.7%
29/79 • Number of events 44 • Up to approximately 5.5 years
All treated participants are included.
|
|
General disorders
OEDEMA PERIPHERAL
|
10.1%
8/79 • Number of events 12 • Up to approximately 5.5 years
All treated participants are included.
|
|
General disorders
PAIN
|
7.6%
6/79 • Number of events 7 • Up to approximately 5.5 years
All treated participants are included.
|
|
General disorders
PYREXIA
|
22.8%
18/79 • Number of events 27 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
BRONCHITIS
|
13.9%
11/79 • Number of events 12 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
CELLULITIS
|
5.1%
4/79 • Number of events 6 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
HERPES SIMPLEX
|
5.1%
4/79 • Number of events 4 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
HERPES ZOSTER
|
8.9%
7/79 • Number of events 10 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.6%
6/79 • Number of events 6 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
OTITIS MEDIA
|
5.1%
4/79 • Number of events 4 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
PNEUMONIA
|
10.1%
8/79 • Number of events 9 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
SINUSITIS
|
19.0%
15/79 • Number of events 24 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
22.8%
18/79 • Number of events 28 • Up to approximately 5.5 years
All treated participants are included.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.3%
5/79 • Number of events 5 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
6.3%
5/79 • Number of events 8 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.1%
4/79 • Number of events 5 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
BLOOD AMYLASE INCREASED
|
7.6%
6/79 • Number of events 9 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
7.6%
6/79 • Number of events 10 • Up to approximately 5.5 years
All treated participants are included.
|
|
Investigations
WEIGHT DECREASED
|
7.6%
6/79 • Number of events 6 • Up to approximately 5.5 years
All treated participants are included.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
7.6%
6/79 • Number of events 9 • Up to approximately 5.5 years
All treated participants are included.
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
11.4%
9/79 • Number of events 9 • Up to approximately 5.5 years
All treated participants are included.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
5.1%
4/79 • Number of events 5 • Up to approximately 5.5 years
All treated participants are included.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
5.1%
4/79 • Number of events 4 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
17.7%
14/79 • Number of events 36 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.5%
13/79 • Number of events 18 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
8.9%
7/79 • Number of events 8 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
5.1%
4/79 • Number of events 4 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
15.2%
12/79 • Number of events 17 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
5.1%
4/79 • Number of events 5 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
12.7%
10/79 • Number of events 12 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
7.6%
6/79 • Number of events 7 • Up to approximately 5.5 years
All treated participants are included.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
31.6%
25/79 • Number of events 53 • Up to approximately 5.5 years
All treated participants are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
5.1%
4/79 • Number of events 6 • Up to approximately 5.5 years
All treated participants are included.
|
|
Nervous system disorders
DIZZINESS
|
20.3%
16/79 • Number of events 24 • Up to approximately 5.5 years
All treated participants are included.
|
|
Nervous system disorders
HEADACHE
|
25.3%
20/79 • Number of events 28 • Up to approximately 5.5 years
All treated participants are included.
|
|
Nervous system disorders
HYPOAESTHESIA
|
17.7%
14/79 • Number of events 21 • Up to approximately 5.5 years
All treated participants are included.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
6.3%
5/79 • Number of events 7 • Up to approximately 5.5 years
All treated participants are included.
|
|
Nervous system disorders
PARAESTHESIA
|
13.9%
11/79 • Number of events 11 • Up to approximately 5.5 years
All treated participants are included.
|
|
Psychiatric disorders
ANXIETY
|
11.4%
9/79 • Number of events 10 • Up to approximately 5.5 years
All treated participants are included.
|
|
Psychiatric disorders
DEPRESSION
|
16.5%
13/79 • Number of events 15 • Up to approximately 5.5 years
All treated participants are included.
|
|
Psychiatric disorders
INSOMNIA
|
16.5%
13/79 • Number of events 13 • Up to approximately 5.5 years
All treated participants are included.
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
5.1%
4/79 • Number of events 5 • Up to approximately 5.5 years
All treated participants are included.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
5.1%
4/79 • Number of events 6 • Up to approximately 5.5 years
All treated participants are included.
|
|
Renal and urinary disorders
POLLAKIURIA
|
6.3%
5/79 • Number of events 7 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
29.1%
23/79 • Number of events 42 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
13.9%
11/79 • Number of events 20 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
6.3%
5/79 • Number of events 7 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
17.7%
14/79 • Number of events 29 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
12.7%
10/79 • Number of events 13 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
6.3%
5/79 • Number of events 5 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
12.7%
10/79 • Number of events 13 • Up to approximately 5.5 years
All treated participants are included.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
7.6%
6/79 • Number of events 9 • Up to approximately 5.5 years
All treated participants are included.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
6.3%
5/79 • Number of events 7 • Up to approximately 5.5 years
All treated participants are included.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
5.1%
4/79 • Number of events 6 • Up to approximately 5.5 years
All treated participants are included.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
6.3%
5/79 • Number of events 7 • Up to approximately 5.5 years
All treated participants are included.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.1%
4/79 • Number of events 6 • Up to approximately 5.5 years
All treated participants are included.
|
|
Skin and subcutaneous tissue disorders
RASH
|
11.4%
9/79 • Number of events 11 • Up to approximately 5.5 years
All treated participants are included.
|
|
Surgical and medical procedures
SINUS OPERATION
|
6.3%
5/79 • Number of events 5 • Up to approximately 5.5 years
All treated participants are included.
|
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 The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to (1) proprietary information that is protected by the provisions contained in paragraph B below, (2) the accuracy of the information contained in the publication, and (3) to ensure that the presentation is fairly balanced and in compliance with FDA regulations.
- Publication restrictions are in place
Restriction type: OTHER