Trial Outcomes & Findings for Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet (NCT NCT01097655)

NCT ID: NCT01097655

Last Updated: 2017-05-23

Results Overview

Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.

• Recruitment status: COMPLETED
• Target enrollment: 3049 participants
• Primary outcome timeframe: Baseline (Week 0) to Week 144
• Results posted on: 2017-05-23

Participant Flow

Participant milestones

Measure	HIV-infected Participants HIV-infected participants starting with Kaletra tablets.
Overall Study STARTED	3049
Overall Study COMPLETED	3039
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	HIV-infected Participants HIV-infected participants starting with Kaletra tablets.
Overall Study Withdrawal by Subject	1
Overall Study Subject Documented Twice	1
Overall Study Did Not Meet Inclusion Criteria	8

Baseline Characteristics

participants with age recorded at Baseline

Baseline characteristics by cohort

Measure	HIV-infected Participants n=3039 Participants HIV-infected participants starting with Kaletra tablets.
Age, Continuous	40.7 years STANDARD_DEVIATION 10.1 • n=2896 Participants • participants with age recorded at Baseline
Sex: Female, Male Female	595 Participants n=3039 Participants
Sex: Female, Male Male	2444 Participants n=3039 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) to Week 144

Population: Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.

Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.

Outcome measures

Measure	HIV-infected Participants n=2981 Participants HIV-infected participants starting with Kaletra tablets.
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 48	213.6 cells/μL Standard Deviation 225.1
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 4	99.8 cells/μL Standard Deviation 145.2
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 12	133.3 cells/μL Standard Deviation 148.7
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 24	160.5 cells/μL Standard Deviation 177.6
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 36	185.9 cells/μL Standard Deviation 181.2
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 60	228.4 cells/μL Standard Deviation 204.6
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 72	250.1 cells/μL Standard Deviation 205.1
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 84	263.8 cells/μL Standard Deviation 214.8
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 96	276.3 cells/μL Standard Deviation 212.8
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 108	291.0 cells/μL Standard Deviation 247.6
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 120	294.3 cells/μL Standard Deviation 216.5
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 132	303.8 cells/μL Standard Deviation 229.3
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count Change at Week 144	316.1 cells/μL Standard Deviation 228.2

PRIMARY outcome

Timeframe: Baseline (Week 0) to Week 144

Population: Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.

Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.

Outcome measures

Measure	HIV-infected Participants n=2959 Participants HIV-infected participants starting with Kaletra tablets.
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 132	-2.94 log copies/mL Standard Deviation 1.36
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 4	-1.90 log copies/mL Standard Deviation 0.97
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 12	-2.53 log copies/mL Standard Deviation 1.23
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 24	-2.83 log copies/mL Standard Deviation 1.35
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 36	-2.89 log copies/mL Standard Deviation 1.40
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 48	-2.89 log copies/mL Standard Deviation 1.41
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 60	-2.93 log copies/mL Standard Deviation 1.38
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 72	-2.92 log copies/mL Standard Deviation 1.36
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 84	-2.92 log copies/mL Standard Deviation 1.37
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 96	-2.93 log copies/mL Standard Deviation 1.38
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 108	-2.93 log copies/mL Standard Deviation 1.39
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 120	-2.92 log copies/mL Standard Deviation 1.36
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load Change at Week 144	-2.97 log copies/mL Standard Deviation 1.34

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 0 to 144

Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').

Outcome measures

Measure	HIV-infected Participants n=3039 Participants HIV-infected participants starting with Kaletra tablets.
Prevalence of Adverse Events (Weeks 0-144), Per Event Hypertriglyceridemia	12.4 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Hypercholesterolemia	19.3 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Low HDL Cholesterol	0.5 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event High LDL Cholesterol	2.3 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Hyperglycemia	3.0 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Hyperbilirubinemia	2.7 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Elevated AST	3.5 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Elevated ALT	4.1 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Elevated γGT	7.3 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Elevated Alkaline Phosphatase	3.1 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Stomatitis	0.6 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Nausea	4.2 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Vomiting	1.5 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Diarrhea	18.3 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Abdominal Pain	2.9 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Mood Disorder	5.0 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Neurocerebellar Disorder	0.6 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Neurocontrol Disorder	0.0 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Headache	1.9 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Fatigue	4.0 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Fever	1.4 percentage of adverse events
Prevalence of Adverse Events (Weeks 0-144), Per Event Not Specified	4.8 percentage of adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 0 to 144

Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').

Outcome measures

Measure	HIV-infected Participants n=3039 Participants HIV-infected participants starting with Kaletra tablets.
Prevalence of Adverse Events (Weeks 0-144), Per Participant Hypertriglyceridemia	14.1 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Hypercholesterolemia	16.3 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Low HDL Cholesterol	1.6 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant High LDL Cholesterol	4.0 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Hyperglycemia	5.8 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Hyperbilirubinemia	3.9 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Elevated AST	6.7 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Elevated ALT	7.5 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Elevated γGT	9.3 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Elevated Alkaline Phosphatase	4.7 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Stomatitis	2.0 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Nausea	11.5 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Vomiting	4.6 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Diarrhea	32.7 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Abdominal Pain	8.0 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Mood Disorder	9.0 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Neurocerebellar Disorder	1.7 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Neurocontrol Disorder	0.0 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Headache	5.2 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Fatigue	8.7 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Fever	4.4 percentage of participants
Prevalence of Adverse Events (Weeks 0-144), Per Participant Not Specified	30.4 percentage of participants

Adverse Events

HIV-infected Participants

Serious events: 79 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	HIV-infected Participants n=3039 participants at risk HIV-infected participants starting with Kaletra tablets.
Infections and infestations TONSILLITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations HELICOBACTER GASTRITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations HERPES VIRUS INFECTION	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations HERPES ZOSTER	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations LEISHMANIASIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations LYMPH NODE TUBERCULOSIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations LYMPHOGRANULOMA VENEREUM	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations MYCOBACTERIUM AVIUM COMPLEX INFECTION	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations OESOPHAGEAL CANDIDIASIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations OPHTHALMIC HERPES ZOSTER	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations ORAL CANDIDIASIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations ORAL HERPES	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations PNEUMOCYSTIS JIROVECII PNEUMONIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations PNEUMONIA	0.16% 5/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations PULMONARY TUBERCULOSIS	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations SALMONELLOSIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations SECONDARY TRANSMISSION	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations SINUSITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Blood and lymphatic system disorders ANAEMIA	0.10% 3/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Blood and lymphatic system disorders EOSINOPHILIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Blood and lymphatic system disorders HAEMOLYTIC ANAEMIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Blood and lymphatic system disorders LYMPHADENITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Blood and lymphatic system disorders MACROCYTOSIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Blood and lymphatic system disorders PANCYTOPENIA	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Blood and lymphatic system disorders PLASMACYTOSIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders ANGINA PECTORIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders ATRIOVENTRICULAR BLOCK SECOND DEGREE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders ATRIOVENTRICULAR DISSOCIATION	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders BRADYCARDIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders BUNDLE BRANCH BLOCK RIGHT	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders CARDIAC VALVE DISEASE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders DEGENERATIVE MITRAL VALVE DISEASE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders EXTRASYSTOLES	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders MYOCARDIAL INFARCTION	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders PLEUROPERICARDITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders RIGHT VENTRICULAR FAILURE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Cardiac disorders VENTRICULAR TACHYCARDIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Endocrine disorders HYPERTHYROIDISM	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Eye disorders EYE SWELLING	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders ABDOMINAL HERNIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders ABDOMINAL PAIN	0.16% 5/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders ALCOHOLIC PANCREATITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders ANAL FISTULA	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders ASCITES	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders CHRONIC GASTRITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders DIARRHOEA	0.20% 6/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders DIARRHOEA HAEMORRHAGIC	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders DYSPHAGIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders GASTROINTESTINAL DISORDER	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders GINGIVITIS ULCERATIVE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders HAEMATEMESIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders HAEMORRHOIDS	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders INGUINAL HERNIA	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders LEUKOPLAKIA ORAL	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders NAUSEA	0.13% 4/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders OESOPHAGITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders PANCREATIC CYST	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders PANCREATITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders PROCTALGIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders SALIVARY GLAND CYST	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Gastrointestinal disorders VOMITING	0.10% 3/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
General disorders ASTHENIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
General disorders CHEST PAIN	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
General disorders CHILLS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
General disorders DRUG INTOLERANCE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
General disorders DRUG WITHDRAWAL SYNDROME	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.13% 4/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
General disorders PAIN	0.10% 3/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
General disorders PYREXIA	0.16% 5/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Hepatobiliary disorders HEPATIC LESION	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Immune system disorders IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations AIDS DEMENTIA COMPLEX	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations ACQUIRED IMMUNODEFICIENCY SYNDROME	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations ANAL ABSCESS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations CHLAMYDIAL INFECTION	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations CYTOMEGALOVIRUS COLITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations ENDOCARDITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations FUNGAL OESOPHAGITIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations GASTROENTERITIS	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Infections and infestations GASTROINTESTINAL INFECTION	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Injury, poisoning and procedural complications FALL	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.10% 3/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Investigations BLOOD TRIGLYCERIDES INCREASED	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Investigations CYTOMEGALOVIRUS TEST POSITIVE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Investigations GENERAL PHYSICAL CONDITION ABNORMAL	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Investigations WEIGHT DECREASED	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Metabolism and nutrition disorders DECREASED APPETITE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Musculoskeletal and connective tissue disorders INGUINAL MASS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.10% 3/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Musculoskeletal and connective tissue disorders SPINAL PAIN	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANAL CANCER	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANAPLASTIC LARGE CELL LYMPHOMA T- AND NULL-CELL TYPE STAGE IV	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANOGENITAL WARTS	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BURKITT'S LYMPHOMA	0.10% 3/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE)	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC CANCER	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) KAPOSI'S SARCOMA	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PAPILLOMA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PLASMABLASTIC LYMPHOMA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders ATAXIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders BALANCE DISORDER	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders CEREBRAL ARTERIOSCLEROSIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders CEREBRAL ATROPHY	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders CEREBRAL INFARCTION	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders DISTURBANCE IN ATTENTION	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders FACIAL PARESIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders HEADACHE	0.10% 3/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders HYPOAESTHESIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders MEMORY IMPAIRMENT	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders MENINGEAL DISORDER	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders PARAESTHESIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders RADICULOPATHY	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Nervous system disorders SOMNOLENCE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Pregnancy, puerperium and perinatal conditions ABORTION	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Pregnancy, puerperium and perinatal conditions ABORTION MISSED	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.10% 3/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Pregnancy, puerperium and perinatal conditions MATERNAL CONDITION AFFECTING FOETUS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Pregnancy, puerperium and perinatal conditions PLACENTAL INSUFFICIENCY	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Pregnancy, puerperium and perinatal conditions PREMATURE BABY	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Psychiatric disorders APATHY	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Psychiatric disorders CONFUSIONAL STATE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Psychiatric disorders DELIRIUM	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Psychiatric disorders DEPRESSION	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Psychiatric disorders DISORIENTATION	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Renal and urinary disorders HYDRONEPHROSIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Renal and urinary disorders NEPHROLITHIASIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Renal and urinary disorders NOCTURIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Renal and urinary disorders RENAL CYST	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Renal and urinary disorders RENAL FAILURE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Renal and urinary disorders URINARY BLADDER POLYP	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Reproductive system and breast disorders ADENOMYOSIS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Reproductive system and breast disorders MENOMETRORRHAGIA	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Reproductive system and breast disorders PROSTATIC MASS	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.07% 2/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Respiratory, thoracic and mediastinal disorders COUGH	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.10% 3/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Respiratory, thoracic and mediastinal disorders RALES	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
Surgical and medical procedures ABORTION INDUCED	0.03% 1/3039 • Through Week 144 Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie (prior sponsor Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER