Trial Outcomes & Findings for Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia (NCT NCT01275625)
NCT ID: NCT01275625
Last Updated: 2014-03-03
Results Overview
Participants' responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
98 participants
Primary outcome timeframe
48 weeks
Results posted on
2014-03-03
Participant Flow
This report presents results of a 48 week study conducted at 8 centers in Russia. A total of 98 subjects were enrolled in the study; however, one site was closed and data from this site was deemed unusable, thus in total 77 subjects were included in the analysis.
Treatment naïve Human Immuno Deficiency Virus (HIV) infected participants aged 18 years at screening were enrolled. Participants were required to meet all eligibility criteria prior to randomization into the study.
Participant milestones
| Measure |
Maraviroc+Combivir
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Overall Study
STARTED
|
77
|
|
Overall Study
Treated
|
77
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Maraviroc+Combivir
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia
Baseline characteristics by cohort
| Measure |
Maraviroc+Combivir
n=77 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Age, Continuous
|
35.2 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Full Analysis Set (FAS) Population included those participants who had taken at least 1 dose of the study drug.
Participants' responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
Outcome measures
| Measure |
Maraviroc+Combivir
n=77 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.
|
77.92 Percentage of participants
Interval 68.01 to 87.84
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48Population: FAS Population included those participants who had taken at least 1 dose of the study drug.
Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
Outcome measures
| Measure |
Maraviroc+Combivir
n=77 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Baseline (N= 77)
|
0.00 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Week 4 (N= 77)
|
7.79 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Week 8 (N= 75)
|
26.67 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Week 12 (N= 76)
|
48.68 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Week 20 (N= 73)
|
78.08 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Week 24 (N= 73)
|
83.56 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Week 36 (N= 68)
|
89.71 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Week 48 (N= 65)
|
92.31 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48Population: FAS Population included those participants who had taken at least 1 dose of the study drug.
Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
Outcome measures
| Measure |
Maraviroc+Combivir
n=77 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
Baseline (N= 77)
|
0.00 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
Week 4 (N= 77)
|
41.56 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
Week 8 (N= 75)
|
72.00 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
Week 12 (N= 76)
|
89.47 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
Week 20 (N= 73)
|
91.78 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
Week 24 (N= 73)
|
91.78 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
Week 36 (N= 68)
|
97.06 Percentage of participants
|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
Week 48 (N= 65)
|
95.38 Percentage of participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: FAS Population included those participants who had taken at least 1 dose of the study drug.
Virologic failure defined as: failure to achieve a reduction from baseline in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification \[LLOQ\]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL \>0.5 log10 copies/mL; or a HIV 1 RNA level of \>1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Participants with Time to loss of virologic response (defined by level of \<50 copies/mL) failure were classified as rebounders or non-responders.
Outcome measures
| Measure |
Maraviroc+Combivir
n=77 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Virologic Response: Rate of Virologic Failure at Week 48.
Responders
|
60 Participants
|
|
Virologic Response: Rate of Virologic Failure at Week 48.
Rebounders
|
1 Participants
|
|
Virologic Response: Rate of Virologic Failure at Week 48.
Non-response
|
15 Participants
|
|
Virologic Response: Rate of Virologic Failure at Week 48.
Death
|
1 Participants
|
|
Virologic Response: Rate of Virologic Failure at Week 48.
Discontinued before Week 48 due to Adverse Events
|
4 Participants
|
|
Virologic Response: Rate of Virologic Failure at Week 48.
Discontinued before Week 48 for other reasons
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: FAS Population included those participants who had taken at least 1 dose of the study drug.
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count
Outcome measures
| Measure |
Maraviroc+Combivir
n=64 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
|
165.53 cells/microliter (cells/mcL)
Standard Deviation 163.65
|
SECONDARY outcome
Timeframe: Week 48Population: FAS Population included those participants who had taken at least 1 dose of the study drug.
Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count
Outcome measures
| Measure |
Maraviroc+Combivir
n=64 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
|
8.07 Percent
Standard Deviation 7.14
|
SECONDARY outcome
Timeframe: Week 48Population: FAS Population included those participants who had taken at least 1 dose of the study drug.
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.
Outcome measures
| Measure |
Maraviroc+Combivir
n=64 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
|
-112.96 cells/mcL
Standard Deviation 361.85
|
SECONDARY outcome
Timeframe: Week 48Population: FAS Population included those participants who had taken at least 1 dose of the study drug.
Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count.
Outcome measures
| Measure |
Maraviroc+Combivir
n=64 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
|
-8.59 Percent
Standard Deviation 9.28
|
SECONDARY outcome
Timeframe: Week 48Population: FAS Population included those participants who had taken at least 1 dose of the study drug.
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.
Outcome measures
| Measure |
Maraviroc+Combivir
n=64 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.
|
0.33 Ratio
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Screening to Week 48 or Time of treatment FailurePopulation: All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis.
The viral genotypes were captured at Baseline and at treatment failure or Early termination and any resistance-associated mutations summarized descriptively at Week 48 for the Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs)drug classes.
Outcome measures
| Measure |
Maraviroc+Combivir
n=77 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Number of Participants With Genotypic Resistance.
Participants with genotype reported
|
8 Participants
|
|
Number of Participants With Genotypic Resistance.
Participants with Emergent NRTI mutations
|
5 Participants
|
SECONDARY outcome
Timeframe: Screening to Week 48 or Time of treatment FailurePopulation: All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis.
Change in tropism were summarized at the time of treatment failure or Early Termination (note: this was performed for participants with viral load \> 400 copies/mL only).
Outcome measures
| Measure |
Maraviroc+Combivir
n=77 Participants
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.
Tropism change (n= 8)
|
0 Participants
|
|
Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.
Reduced Maraviroc susceptibility (n= 3)
|
0 Participants
|
Adverse Events
Maraviroc+Combivir
Serious events: 2 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maraviroc+Combivir
n=77 participants at risk
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Maraviroc+Combivir
n=77 participants at risk
All participants received Maraviroc (300 milligram \[mg\] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
7/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.2%
4/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abnormal faeces
|
2.6%
2/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.9%
3/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
11.7%
9/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
4/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
2.6%
2/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Malaise
|
10.4%
8/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Performance status decreased
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
3.9%
3/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Chronic sinusitis
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes simplex
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Laryngitis
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
2.6%
2/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
11.7%
9/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory tract infection viral
|
6.5%
5/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Salpingo-oophoritis
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth infection
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Vaginitis bacterial
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral rhinitis
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
7/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
7.8%
6/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood pressure increased
|
2.6%
2/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
3.9%
3/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.9%
3/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
7.8%
6/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Intercostal neuralgia
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuritis cranial
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Agitation
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Drug dependence
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Neurogenic bladder
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Nail psoriasis
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Cows milk free diet
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Angina pectoris
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Amylase increased
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Heart rate increased
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Essential hypertension
|
1.3%
1/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
2.6%
2/77 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER