Trial Outcomes & Findings for Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects (NCT NCT01190176)
NCT ID: NCT01190176
Last Updated: 2019-10-30
Results Overview
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
COMPLETED
PHASE3
34 participants
At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
2019-10-30
Participant Flow
This study was conducted by multiple investigators at 20 centres in Canada, Netherlands, Portugal, Russian Federation, Singapore, United Kingdom and the United States.
Although 34 subjects were enrolled in the study, 2 were excluded following eligibility criteria, leading to 32 subjects who started the study.
Participant milestones
| Measure |
HPV-062 Study Subjects Group
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
HPV-062 Study Subjects Group
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
Baseline characteristics by cohort
| Measure |
HPV-062 Study Subjects Group
n=32 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Heritage / African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=13 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12
|
2 Participants
|
PRIMARY outcome
Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=12 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24
|
3 Participants
|
PRIMARY outcome
Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=9 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36
|
3 Participants
|
PRIMARY outcome
Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=6 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48
|
1 Participants
|
PRIMARY outcome
Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=15 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12
Normal
|
11 Participants
|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12
ASC-US
|
2 Participants
|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12
LSIL
|
2 Participants
|
PRIMARY outcome
Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=12 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24
Normal
|
11 Participants
|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24
ASC-US
|
1 Participants
|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24
LSIL
|
0 Participants
|
PRIMARY outcome
Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=9 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36
Normal
|
8 Participants
|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36
ASC-US
|
1 Participants
|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36
LSIL
|
0 Participants
|
PRIMARY outcome
Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=6 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48
Normal
|
6 Participants
|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48
ASC-US
|
0 Participants
|
|
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48
LSIL
|
0 Participants
|
PRIMARY outcome
Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=15 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Referral to Colposcopy at Month 12
Colposcopy referral · Yes
|
4 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 12
Colposcopy referral · No
|
11 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 12
Colposcopy performed · Yes
|
4 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 12
Colposcopy performed · No
|
11 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 12
Algorithm respected · Yes
|
4 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 12
Algorithm respected · No
|
0 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 12
Lesion · Yes
|
1 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 12
Lesion · No
|
3 Participants
|
PRIMARY outcome
Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=12 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Referral to Colposcopy at Month 24
Colposcopy referral · Yes
|
1 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 24
Colposcopy referral · No
|
11 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 24
Colposcopy performed · Yes
|
1 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 24
Colposcopy performed · No
|
11 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 24
Algorithm respected · Yes
|
1 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 24
Algorithm respected · No
|
0 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 24
Lesion · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 24
Lesion · No
|
1 Participants
|
PRIMARY outcome
Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=9 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Referral to Colposcopy at Month 36
Colposcopy performed · Yes
|
3 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 36
Colposcopy performed · No
|
6 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 36
Colposcopy referral · Yes
|
3 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 36
Colposcopy referral · No
|
6 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 36
Algorithm respected · Yes
|
3 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 36
Algorithm respected · No
|
0 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 36
Lesion · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 36
Lesion · No
|
3 Participants
|
PRIMARY outcome
Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=6 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Referral to Colposcopy at Month 48
Algorithm respected · No
|
1 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 48
Colposcopy referral · Yes
|
1 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 48
Colposcopy referral · No
|
5 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 48
Colposcopy performed · Yes
|
2 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 48
Colposcopy performed · No
|
4 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 48
Algorithm respected · Yes
|
1 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 48
Lesion · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Colposcopy at Month 48
Lesion · No
|
2 Participants
|
PRIMARY outcome
Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=4 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Referral to Treatment at Month 12
Treatment referral · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Treatment at Month 12
Treatment referral · No
|
4 Participants
|
|
Number of Subjects With Referral to Treatment at Month 12
Treatment done · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Treatment at Month 12
Treatment done · No
|
4 Participants
|
PRIMARY outcome
Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=1 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Referral to Treatment at Month 24
Treatment referral · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Treatment at Month 24
Treatment referral · No
|
1 Participants
|
|
Number of Subjects With Referral to Treatment at Month 24
Treatment done · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Treatment at Month 24
Treatment done · No
|
1 Participants
|
PRIMARY outcome
Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=3 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Referral to Treatment at Month 36
Treatment referral · Yes
|
1 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Treatment referral · No
|
2 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Treatment done · Yes
|
1 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Treatment done · No
|
2 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Loop excision of cervix · Yes
|
1 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Loop excision of cervix · No
|
0 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Loop cone of cervix · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Loop cone of cervix · No
|
1 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Cold knife cone of cervix · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Cold knife cone of cervix · No
|
1 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Laser excision cone of cervix · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Laser excision cone of cervix · No
|
1 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Other · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Treatment at Month 36
Other · No
|
1 Participants
|
PRIMARY outcome
Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
Outcome measures
| Measure |
HPV-062 Study Subjects Group
n=2 Participants
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
|
|---|---|
|
Number of Subjects With Referral to Treatment at Month 48
Treatment referral · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Treatment at Month 48
Treatment referral · No
|
2 Participants
|
|
Number of Subjects With Referral to Treatment at Month 48
Treatment done · Yes
|
0 Participants
|
|
Number of Subjects With Referral to Treatment at Month 48
Treatment done · No
|
2 Participants
|
Adverse Events
HPV-062 Study Subjects Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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