Trial Outcomes & Findings for Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292) (NCT NCT02131233)
NCT ID: NCT02131233
Last Updated: 2019-01-30
Results Overview
From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA "snapshot" approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
802 participants
Primary outcome timeframe
Week 48
Results posted on
2019-01-30
Participant Flow
These results stop at Week 96.
Participant milestones
| Measure |
Reformulated Raltegravir
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
533
|
269
|
|
Overall Study
Treated
|
531
|
266
|
|
Overall Study
COMPLETED
|
467
|
227
|
|
Overall Study
NOT COMPLETED
|
66
|
42
|
Reasons for withdrawal
| Measure |
Reformulated Raltegravir
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Overall Study
Not Treated
|
2
|
3
|
|
Overall Study
Adverse Event
|
7
|
6
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
14
|
13
|
|
Overall Study
Non-Compliance With Study Drug
|
8
|
5
|
|
Overall Study
Physician Decision
|
7
|
0
|
|
Overall Study
Pregnancy
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
18
|
11
|
Baseline Characteristics
Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)
Baseline characteristics by cohort
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
Total
n=797 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.4 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
36.9 Years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
35.9 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
440 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
674 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: All randomized participants who received at least one dose of study treatment
From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA "snapshot" approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48
|
88.9 Percentage of participants
Interval 85.9 to 91.4
|
88.3 Percentage of participants
Interval 83.9 to 91.9
|
SECONDARY outcome
Timeframe: Week 96Population: All randomized participants who received at least one dose of study treatment
From blood samples collected at week 96, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA "snapshot" approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 96
|
81.5 Percentage of participants
Interval 85.9 to 91.4
|
80.1 Percentage of participants
Interval 83.9 to 91.9
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: All randomized participants who received at least one dose of study treatment and have baseline data. The Observed Failure (OF) approach to handling missing values assumed baseline-carry-forward for all failures, and excluded other missing values.
CD4 cells were counted from blood collected at baseline and week 48, and the change from baseline determined from week 48 minus baseline values.
Outcome measures
| Measure |
Reformulated Raltegravir
n=499 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=251 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
|
232.0 cells/mm^3
Interval 214.6 to 249.4
|
234.1 cells/mm^3
Interval 212.8 to 255.3
|
SECONDARY outcome
Timeframe: Baseline and Week 96Population: All randomized participants who received at least one dose of study treatment and have baseline data. The Observed Failure (OF) approach to handling missing values assumed baseline-carry-forward for all failures, and excluded other missing values.
CD4 cells were counted from blood collected at baseline and week 96, and the change from baseline determined from week 96 minus baseline values.
Outcome measures
| Measure |
Reformulated Raltegravir
n=482 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=235 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 96
|
261.6 cells/mm^3
Interval 242.9 to 280.3
|
262.2 cells/mm^3
Interval 236.4 to 288.0
|
SECONDARY outcome
Timeframe: Up to Week 48Population: All randomized participants who received at least one dose of study treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants With an Adverse Event (AE) at Week 48
|
83.2 Percentage of participants
|
88.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)Population: All randomized participants who received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants With an AE After 96 Weeks of Treatment
|
90.8 Percentage of participants
|
94.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: All randomized participants who received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants With a Drug-Related AE at Week 48
|
25.0 Percentage of participants
|
27.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)Population: All randomized participants who received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants With a Drug-Related AE After 96 Weeks of Treatment
|
26.4 Percentage of participants
|
28.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: All randomized participants who received at least one dose of study treatment.
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants With a Serious Adverse Event (SAE) at Week 48
|
6.2 Percentage of participants
|
9.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)Population: All randomized participants who received at least one dose of study treatment.
A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants With a SAE After 96 Weeks of Treatment
|
9.6 Percentage of participants
|
15.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: All randomized participants who received at least one dose of study treatment.
A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician evaluated whether or not a SAE is drug-related.
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants With a Serious and Drug-Related AE at Week 48
|
0.2 Percentage of participants
|
0.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)Population: All randomized participants who received at least one dose of study treatment.
A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician evaluated whether or not a SAE is drug-related.
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants With a Serious and Drug-Related AE After 96 Weeks of Treatment
|
0.2 Percentage of participants
|
0.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: All randomized participants who received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48
|
1.1 Percentage of participants
|
2.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 96Population: All randomized participants who received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE
Outcome measures
| Measure |
Reformulated Raltegravir
n=531 Participants
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir
n=266 Participants
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Percentage of Participants Who Discontinued From Drug Therapy Due to an AE up to Week 96
|
1.3 Percentage of participants
|
2.3 Percentage of participants
|
Adverse Events
Raltegravir 1200 mg QD + Truvada
Serious events: 51 serious events
Other events: 375 other events
Deaths: 0 deaths
Raltegravir 400 mg BID + Truvada
Serious events: 42 serious events
Other events: 184 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Raltegravir 1200 mg QD + Truvada
n=531 participants at risk
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir 400 mg BID + Truvada
n=266 participants at risk
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Goitre
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intussusception
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Proctitis
|
0.38%
2/531 • Number of events 2 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Drug ineffective
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Peripheral swelling
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Abdominal wall abscess
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Acquired immunodeficiency syndrome
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Dengue fever
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Hepatitis C
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lymphogranuloma venereum
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 2 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Meningitis tuberculous
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Plasmodium vivax infection
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Proctitis chlamydial
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Proctitis infectious
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Syphilis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tuberculosis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Varicella
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Vestibular neuronitis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Lipase increased
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of salivary gland
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Immunoblastic lymphoma
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Facial paresis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Seizure
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Alcoholism
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.75%
4/531 • Number of events 4 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.75%
2/266 • Number of events 2 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.38%
2/531 • Number of events 2 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Schizophrenia
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.19%
1/531 • Number of events 2 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/531 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.38%
1/266 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.19%
1/531 • Number of events 1 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
0.00%
0/266 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Raltegravir 1200 mg QD + Truvada
n=531 participants at risk
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Raltegravir 400 mg BID + Truvada
n=266 participants at risk
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
46/531 • Number of events 57 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
4.5%
12/266 • Number of events 15 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.4%
71/531 • Number of events 82 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
12.8%
34/266 • Number of events 42 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
13.6%
72/531 • Number of events 88 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
12.8%
34/266 • Number of events 38 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
42/531 • Number of events 45 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
7.5%
20/266 • Number of events 24 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
7.5%
40/531 • Number of events 44 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
6.4%
17/266 • Number of events 19 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
2.6%
14/531 • Number of events 16 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
5.3%
14/266 • Number of events 19 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
4.9%
26/531 • Number of events 30 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
5.6%
15/266 • Number of events 16 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
5.5%
29/531 • Number of events 32 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
5.3%
14/266 • Number of events 16 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
5.8%
31/531 • Number of events 41 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
6.8%
18/266 • Number of events 22 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
12.2%
65/531 • Number of events 88 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
9.8%
26/266 • Number of events 35 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Syphilis
|
5.3%
28/531 • Number of events 30 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
7.1%
19/266 • Number of events 21 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.6%
67/531 • Number of events 90 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
10.2%
27/266 • Number of events 37 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
5.5%
29/531 • Number of events 35 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
6.4%
17/266 • Number of events 25 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.9%
26/531 • Number of events 31 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
6.8%
18/266 • Number of events 19 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
27/531 • Number of events 32 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
2.6%
7/266 • Number of events 9 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
39/531 • Number of events 47 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
5.3%
14/266 • Number of events 15 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
7.3%
39/531 • Number of events 46 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
7.1%
19/266 • Number of events 20 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
15.8%
84/531 • Number of events 106 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
13.9%
37/266 • Number of events 45 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
3.2%
17/531 • Number of events 19 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
5.6%
15/266 • Number of events 17 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
5.8%
31/531 • Number of events 31 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
6.8%
18/266 • Number of events 18 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
40/531 • Number of events 48 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
6.4%
17/266 • Number of events 19 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
18/531 • Number of events 21 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
6.4%
17/266 • Number of events 18 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
30/531 • Number of events 35 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
4.9%
13/266 • Number of events 14 • Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
All randomized participants who received at least one dose of study treatment.
|
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 must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER