Trial Outcomes & Findings for VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies. (NCT NCT00116844)
NCT ID: NCT00116844
Last Updated: 2018-02-12
Results Overview
Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or subclinical (no genital lesions). Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
73 participants
Primary outcome timeframe
Up to Day 60 of each treatment period (up to 160 days)
Results posted on
2018-02-12
Participant Flow
From March-2005 to January-2006, 73 participants from 13 centers in the United States were randomized into the study (36 in VALTREX™-Placebo, and 37 in Placebo-VALTEX treatment sequence). One participant in each treatment sequence did not receive study medication and intent-to-treat exposed (ITTE) population was comprised of 71 participants.
Eligible male or female immunocompetent participants in general good health were enrolled. Additionally, participants must be Herpes Simplex Virus Type 2 (HSV-2) seropositive at screening. VALTREX (valacyclovir hydrochloride) is registered trademark of GlaxoSmithKline.
Participant milestones
| Measure |
Sequence 1: VALTREX 1 g Once Daily, Placebo
Participants randomized to this sequence received VALTREX 1 gram (g) once daily for 60 days, to be taken as two 500 milligram (mg) caplets in Period 1 followed by matching placebo for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
|
Sequence 2: Placebo, VALTREX 1 g Once Daily
Participants randomized to this sequence received matching placebo for 60 days, to be taken as two 500 mg caplets in Period 1 followed by VALTREX 1 g once daily for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
|
|---|---|---|
|
Period 1: Treatment Period 1 (60 Days)
STARTED
|
35
|
36
|
|
Period 1: Treatment Period 1 (60 Days)
COMPLETED
|
28
|
33
|
|
Period 1: Treatment Period 1 (60 Days)
NOT COMPLETED
|
7
|
3
|
|
Period 2: Washout Period (7 Days)
STARTED
|
28
|
33
|
|
Period 2: Washout Period (7 Days)
COMPLETED
|
28
|
33
|
|
Period 2: Washout Period (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 1: Treatment Period 2 (60 Days)
STARTED
|
28
|
33
|
|
Period 1: Treatment Period 2 (60 Days)
COMPLETED
|
24
|
28
|
|
Period 1: Treatment Period 2 (60 Days)
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Sequence 1: VALTREX 1 g Once Daily, Placebo
Participants randomized to this sequence received VALTREX 1 gram (g) once daily for 60 days, to be taken as two 500 milligram (mg) caplets in Period 1 followed by matching placebo for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
|
Sequence 2: Placebo, VALTREX 1 g Once Daily
Participants randomized to this sequence received matching placebo for 60 days, to be taken as two 500 mg caplets in Period 1 followed by VALTREX 1 g once daily for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
|
|---|---|---|
|
Period 1: Treatment Period 1 (60 Days)
Lost to Follow-up
|
1
|
1
|
|
Period 1: Treatment Period 1 (60 Days)
Protocol Violation
|
0
|
1
|
|
Period 1: Treatment Period 1 (60 Days)
Withdrawal by Subject
|
5
|
0
|
|
Period 1: Treatment Period 1 (60 Days)
Other
|
1
|
1
|
|
Period 1: Treatment Period 2 (60 Days)
Adverse Event
|
1
|
0
|
|
Period 1: Treatment Period 2 (60 Days)
Lost to Follow-up
|
2
|
1
|
|
Period 1: Treatment Period 2 (60 Days)
Other
|
0
|
2
|
|
Period 1: Treatment Period 2 (60 Days)
Protocol Violation
|
0
|
1
|
|
Period 1: Treatment Period 2 (60 Days)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.
Baseline characteristics by cohort
| Measure |
Sequence 1: VALTREX 1 g Once Daily, Placebo
n=35 Participants
Participants randomized to this sequence received VALTREX 1 g once daily for 60 days, to be taken as two 500 mg caplets in Period 1 followed by matching placebo for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
|
Sequence 2: Placebo, VALTREX 1 g Once Daily
n=36 Participants
Participants randomized to this sequence received matching placebo for 60 days, to be taken as two 500 mg caplets in Period 1 followed by VALTREX 1 g once daily for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.1 Years
STANDARD_DEVIATION 12.96 • n=5 Participants
|
35.8 Years
STANDARD_DEVIATION 11.69 • n=7 Participants
|
37.4 Years
STANDARD_DEVIATION 12.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 60 of each treatment period (up to 160 days)Population: The intent-to-treat crossover (ITTC) population was defined as consisting of all participants who received at least one dose of investigational product and had at least one PCR swabbing result in each treatment period. Only those participants with data available at the indicated time points were analyzed.
Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or subclinical (no genital lesions). Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.
Outcome measures
| Measure |
VALTREX 1 g Once Daily
n=56 Participants
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
Placebo
n=56 Participants
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
|---|---|---|
|
Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2
|
1.5 Percentage of days
Standard Deviation 5.3
|
5.1 Percentage of days
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Up to Day 60 of each treatment period (up to 160 days)Population: ITTC population. Only those participants with data available at the indicated time points were analyzed.
The percent of days with total (clinical and subclinical) HSV-2 shedding was defined as the percent of all days with PCR data for which HSV-2 shedding was detected. Mean percent of days with total HSV-2 shedding was the statistic used to summarize this endpoint for each treatment group. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). The total shedding rate was defined for each participant as the percentage of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.
Outcome measures
| Measure |
VALTREX 1 g Once Daily
n=56 Participants
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
Placebo
n=56 Participants
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
|---|---|---|
|
Mean Percent Days of Total HSV-2 Shedding
|
1.5 Percentage of days
Standard Deviation 5.2
|
5.5 Percentage of days
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Up to Day 60 of each treatment period (up to 160 days)Population: ITTC population. Only those participants with data available at the indicated time points were analyzed.
The number of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Outcome measures
| Measure |
VALTREX 1 g Once Daily
n=56 Participants
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
Placebo
n=56 Participants
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
|---|---|---|
|
Number of Participants With no Shedding
Shedding
|
9 Participants
|
26 Participants
|
|
Number of Participants With no Shedding
No Shedding
|
47 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Up to Day 60 of each treatment period (up to 160 days)Population: ITTC population. Only those participants with data available at the indicated time points were analyzed.
The subclinical shedding rate was defined for each participant as the total number of subclinical days on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with subclinical shedding was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all subclinical shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Outcome measures
| Measure |
VALTREX 1 g Once Daily
n=5 Participants
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
Placebo
n=5 Participants
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
|---|---|---|
|
Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding
|
4.5 DNA copies per day
Standard Deviation 0.9
|
4.6 DNA copies per day
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Up to Day 60 of each treatment period (up to 160 days)Population: ITTC population. Only those participants with data available at the indicated time points were analyzed.
The total shedding rate was defined for each participant as the total number of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with total shedding (clinical and subclinical) was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Outcome measures
| Measure |
VALTREX 1 g Once Daily
n=7 Participants
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
Placebo
n=7 Participants
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
|---|---|---|
|
Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding
|
4.5 DNA copies per day
Standard Deviation 0.9
|
5.2 DNA copies per day
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Up to Day 60 of each treatment period (up to 160 days)Population: ITTC population. Only those participants with data available at the indicated time points were analyzed.
Participants who have recognized clinical signs/symptoms of genital herpes infection during the study. Participants were educated on recognizing signs and symptoms of genital herpes infection at the screening/randomization visit. Genital examinations was conducted at the randomization and genital herpes outbreak visits.
Outcome measures
| Measure |
VALTREX 1 g Once Daily
n=56 Participants
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
Placebo
n=56 Participants
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
|---|---|---|
|
Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study
No Signs/Symptoms
|
88 Percentage of participants
|
77 Percentage of participants
|
|
Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study
Signs/symptoms Present
|
13 Percentage of participants
|
23 Percentage of participants
|
Adverse Events
Valtrex 1 g Once Daily
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valtrex 1 g Once Daily
n=65 participants at risk
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
Placebo
n=63 participants at risk
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
Other adverse events
| Measure |
Valtrex 1 g Once Daily
n=65 participants at risk
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
Placebo
n=63 participants at risk
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
2/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
12.7%
8/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
2/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
7.9%
5/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Vaginitis bacterial
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
4.8%
3/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
4.8%
3/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Gastroenteritis viral
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Sinusitis
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Bronchitis viral
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Furuncle
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Otitis media
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Pelvic inflammatory disease
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
2/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
3.2%
2/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Nausea
|
4.6%
3/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
4.8%
3/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Stomach discomfort
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
3.2%
2/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Gastrointestinal disorders
Oral soft tissue disorder
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Nervous system disorders
Headache
|
4.6%
3/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
6.3%
4/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Nervous system disorders
Dizziness
|
6.2%
4/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Nervous system disorders
Migraine
|
3.1%
2/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Nervous system disorders
Tension headache
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
General disorders
Fatigue
|
3.1%
2/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
General disorders
Influenza like illness
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
General disorders
Malaise
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
General disorders
Oedema peripheral
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
General disorders
Pyrexia
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
2/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
3.2%
2/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
3.2%
2/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Injury, poisoning and procedural complications
Failure of implant
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Reproductive system and breast disorders
Breast tenderness
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Investigations
Blood urine present
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Investigations
Eosinophil count increased
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Investigations
Metamyelocyte count increased
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Investigations
Myelocyte count increased
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Investigations
Weight increased
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Renal and urinary disorders
Dysuria
|
1.5%
1/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
0.00%
0/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Eye disorders
Eye discharge
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/65 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
1.6%
1/63 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER