Infections, Papillomavirus
Conditions
Keywords
HPV, Papillomavirus, Human papillomavirus, Cervical cancer, HPV vaccine
Brief summary
This study is designed to provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT00122681 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their last NCT00122681 study visit (Visit 10, Month 48). This follow-up study will also be offered to subjects who were pregnant at their last NCT00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at that visit. The objectives & outcome measures of the primary phase (study 008/580299) are presented in a separate protocol posting (NCT00122681).
Interventions
Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study. Subjects received 3 doses of Cervarix/Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent obtained from the subject prior to enrolment. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A subject previously enrolled in the study NCT00122681 and who fulfils either of the following criteria: * displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48). or \- was pregnant at her last visit of the NCT00122681 study (Visit 10, Month 48) so that no cervical sample could be collected at that visit.
Exclusion criteria
* A subject who displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48). * A subject who had a cervical lesion at her last NCT00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT00122681 exit colposcopy. * A subject for whom the cervical cytology results from the last NCT00122681 study visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy. If at the time of enrolment the subject experiences heavy bleeding (menstruation or other) or heavy vaginal discharge, or is pregnant, the pelvic exam cannot be performed. The subject's first study visit will be deferred until condition is resolved according to investigator's medical judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | At Months 12, 24, 36, 48 | Subjects who presented oncogenic HPV DNA in cervical samples by HPV DNA testing. The presence of oncogenic HPV infection was determined by the Hybrid Capture 2 (HCII) test, which detects HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68. Missing = For some of the subjects whose result was indicated as quantity not sufficient (QNS). |
| Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | At Months 12, 24, 36, 48 | Subjects with normal cervical cytology, who were found to be oncogenic HPV DNA positive in two subsequent tests, were referred to colposcopy. The result of the subjects' last HPV-008 study visit was taken into account at Visit 1. Subjects with a single cervical cytology reading of ≥ atypical squamous cells of undetermined significance (ASC-US) positive for oncogenic HPV DNA were referred for colposcopy. Subjects with a single cervical cytology reading of ≥ low grade squamous intraepithelial lesion (LSIL) were referred to colposcopy, irrespective of their oncogenic HPV DNA test result. |
| Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | At Months 12, 24, 36, 48 | Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology. Cervical cytology examination was performed using the ThinPrep PapTest. Note: One subject may have presented with different cytology results at the yearly visit throughout the maximum 4-year follow-up period and therefore may be counted in more than one result category in the analysis. |
| Number of Subjects With Cervical Biopsy Results at Month 12 | At Month 12 | Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations. |
| Number of Subjects With Cervical Biopsy Results at Month 24 | At Month 24 | Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations. |
| Number of Subjects With Cervical Biopsy Results at Month 36 | At Month 36 | Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations. |
| Number of Subjects With Cervical Biopsy Results at Month 48 | At Month 48 | Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations. |
| Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | At Month 12 | If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other. |
| Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | At Month 24 | If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other. |
| Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | At Month 36 | If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other. |
| Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | At Month 48 | If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other. |
| Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal | From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study] | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication. | From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study] | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. |
Countries
Australia, Belgium, Brazil, Canada, Finland, Germany, Italy, Philippines, Spain, Taiwan, Thailand, United Kingdom, United States
Participant flow
Pre-assignment details
Out of the 2022 subjects enrolled in this study, 19 were excluded for reasons of non-eligibility, hence only 2003 started the study.
Participants by arm
| Arm | Count |
|---|---|
| HPV-052 Study Subjects Group The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit. | 2,003 |
| Total | 2,003 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 144 |
| Overall Study | Migrated/moved from study area | 27 |
| Overall Study | Missing confirmed | 4 |
| Overall Study | Other | 18 |
| Overall Study | Withdrawal by Subject | 23 |
Baseline characteristics
| Characteristic | HPV-052 Study Subjects Group |
|---|---|
| Age, Continuous | 24.3 Years STANDARD_DEVIATION 3.06 |
| Race/Ethnicity, Customized Race Arabic/north African | 4 Participants |
| Race/Ethnicity, Customized Race Black | 58 Participants |
| Race/Ethnicity, Customized Race Chinese | 106 Participants |
| Race/Ethnicity, Customized Race East & south east Asian | 549 Participants |
| Race/Ethnicity, Customized Race Hispanic | 21 Participants |
| Race/Ethnicity, Customized Race Indian | 1 Participants |
| Race/Ethnicity, Customized Race Not specified | 50 Participants |
| Race/Ethnicity, Customized Race South Asian | 3 Participants |
| Race/Ethnicity, Customized Race White/Caucasian | 1211 Participants |
| Sex: Female, Male Female | 2003 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2,003 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 2,003 |
Outcome results
Primary
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]
Population: The analysis was based on the Total HPV-052 cohort, which included subjects who had their symptom sheet completed and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal | 216 Participants |
Primary
Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]
Population: The analysis was based on the Total HPV-052 cohort, which included subjects who had their symptom sheet completed and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication. | Subjects with fatal SAEs | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication. | Subjects with any related SAEs | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication. | Subjects with any SAEs due to concurrent GSK medic | 0 Participants |
Primary
Number of Subjects With Cervical Biopsy Results at Month 12
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Time frame: At Month 12
Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | Negative | 76 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | Only CIN1(positive) | 41 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | Only CIN1(negative) | 158 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | Only CIN2 (positive) | 18 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | Only CIN2 (negative) | 181 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | Only CIN3 (positive) | 8 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | Only CIN3 (negative) | 191 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | CIN1 and CIN2 (positive) | 3 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | CIN1 and CIN2(negative) | 196 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | CIN1 and CIN3(positive) | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | CIN1 and CIN3 (negative) | 198 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | CIN2 and CIN3 (positive) | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | CIN2 and CIN3 (negative) | 198 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | Other | 85 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | CIN1 and CIN2 and CIN3 (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | CIN1 and CIN2 and CIN3 (negative) | 199 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | AIS (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | AIS (negative) | 199 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | Invasive malignancy (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 12 | Invasive malignancy (negative) | 199 Participants |
Primary
Number of Subjects With Cervical Biopsy Results at Month 24
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Time frame: At Month 24
Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | Negative | 38 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | Only CIN1(positive) | 47 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | Only CIN2 (positive) | 8 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | Only CIN2 (negative) | 139 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | Only CIN3 (positive) | 8 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | Only CIN3 (negative) | 139 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | CIN1 and CIN2 (positive) | 2 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | CIN1 and CIN2(negative) | 145 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | CIN1 and CIN3(positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | CIN1 and CIN3 (negative) | 147 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | CIN2 and CIN3 (positive) | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | CIN2 and CIN3 (negative) | 146 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | CIN1 and CIN2 and CIN3 (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | CIN1 and CIN2 and CIN3 (negative) | 147 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | AIS (positive) | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | AIS (negative) | 146 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | Invasive malignancy (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | Invasive malignancy (negative) | 147 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | Other | 56 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 24 | Only CIN1(negative) | 100 Participants |
Primary
Number of Subjects With Cervical Biopsy Results at Month 36
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Time frame: At Month 36
Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | Negative | 31 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | Only CIN1(positive) | 31 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | Only CIN1(negative) | 57 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | Only CIN2 (positive) | 6 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | Only CIN2 (negative) | 82 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | Only CIN3 (positive) | 3 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | Only CIN3 (negative) | 85 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | CIN1 and CIN2 (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | CIN1 and CIN2(negative) | 88 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | CIN1 and CIN3(positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | CIN1 and CIN3 (negative) | 88 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | CIN2 and CIN3 (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | CIN2 and CIN3 (negative) | 88 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | Other | 25 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | CIN1 and CIN2 and CIN3 (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | CIN1 and CIN2 and CIN3 (negative) | 88 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | AIS (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | AIS (negative) | 88 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | Invasive malignancy (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 36 | Invasive malignancy (negative) | 88 Participants |
Primary
Number of Subjects With Cervical Biopsy Results at Month 48
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Time frame: At Month 48
Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | Only CIN1(positive) | 15 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | Only CIN1(negative) | 39 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | Only CIN2 (positive) | 5 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | Only CIN2 (negative) | 49 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | Only CIN3 (positive) | 2 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | CIN1 and CIN2(negative) | 53 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | CIN1 and CIN3(positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | CIN1 and CIN3 (negative) | 54 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | CIN2 and CIN3 (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | Negative | 21 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | Only CIN3 (negative) | 52 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | CIN1 and CIN2 (positive) | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | CIN2 and CIN3 (negative) | 54 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | CIN1 and CIN2 and CIN3 (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | CIN1 and CIN2 and CIN3 (negative) | 54 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | AIS (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | AIS (negative) | 54 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | Invasive malignancy (positive) | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | Invasive malignancy (negative) | 54 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cervical Biopsy Results at Month 48 | Other | 11 Participants |
Primary
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Subjects with normal cervical cytology, who were found to be oncogenic HPV DNA positive in two subsequent tests, were referred to colposcopy. The result of the subjects' last HPV-008 study visit was taken into account at Visit 1. Subjects with a single cervical cytology reading of ≥ atypical squamous cells of undetermined significance (ASC-US) positive for oncogenic HPV DNA were referred for colposcopy. Subjects with a single cervical cytology reading of ≥ low grade squamous intraepithelial lesion (LSIL) were referred to colposcopy, irrespective of their oncogenic HPV DNA test result.
Time frame: At Months 12, 24, 36, 48
Population: The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy(Month24),Unsatisfactory | 14 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy (Month 24), Missing | 4 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 48) No | 1867 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 12) Yes | 572 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 12) No | 1429 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 12) Missing | 2 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Algorithm respected (Month 12) Yes | 371 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Algorithm respected (Month 12) No | 21 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy (Month12),Satisfactory | 370 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy (Month12), Unsatisfactory | 18 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy (Month 12), Missing | 4 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 24) Yes | 385 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 24) No | 1615 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 24) Missing | 3 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Algorithm respected (Month 24) Yes | 254 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Algorithm respected (Month 24) No | 8 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Algorithm respected (Month 24) Missing | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy (Month24), Satisfactory | 245 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 36) Yes | 224 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 36) No | 1776 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 36) Missing | 3 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Algorithm respected (Month 36) Yes | 154 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Algorithm respected (Month 36) No | 4 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy (Month36), Satisfactory | 150 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy(Month36), Unsatisfactory | 7 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy (Month 36), Missing | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 48) Yes | 133 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy referral (Month 48) Missing | 3 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Algorithm respected (Month 48) Yes | 96 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Algorithm respected (Month 48) No | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy (Month48), Satisfactory | 92 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy (Month48), Unsatisfactory | 3 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Colposcopy Referral and Colposcopy Adequacy | Colposcopy adequacy (Month 48), Missing | 1 Participants |
Primary
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology. Cervical cytology examination was performed using the ThinPrep PapTest. Note: One subject may have presented with different cytology results at the yearly visit throughout the maximum 4-year follow-up period and therefore may be counted in more than one result category in the analysis.
Time frame: At Months 12, 24, 36, 48
Population: The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | Normal, Month 48 | 206 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | ASC-H, Month 48 | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | LSIL, Month 48 | 16 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | HSIL, Month 48 | 6 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | AGC, Month 48 | 2 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | Normal, Month 12 | 1193 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | ASC-US, Month 12 | 154 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | ASC-H, Month 12 | 8 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | LSIL, Month 12 | 100 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | HSIL, Month 12 | 8 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | AGC, Month 12 | 4 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | Normal, Month 24 | 662 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | ASC-US, Month 24 | 117 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | ASC-H, Month 24 | 11 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | LSIL, Month 24 | 68 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | HSIL, Month 24 | 7 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | AGC, Month 24 | 2 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | Normal, Month 36 | 390 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | ASC-US, Month 36 | 58 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | ASC-H, Month 36 | 4 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | LSIL, Month 36 | 34 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | HSIL, Month 36 | 5 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | AGC, Month 36 | 3 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest | ASC-US, Month 48 | 28 Participants |
Primary
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Subjects who presented oncogenic HPV DNA in cervical samples by HPV DNA testing. The presence of oncogenic HPV infection was determined by the Hybrid Capture 2 (HCII) test, which detects HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68. Missing = For some of the subjects whose result was indicated as quantity not sufficient (QNS).
Time frame: At Months 12, 24, 36, 48
Population: The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Positive DNA (Month 12 Post HPV-008) | 615 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Negative DNA (Month 12 Post HPV-008) | 828 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Missing DNA (Month 12 Post HPV-008) | 24 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Positive DNA (Month 24 Post HPV-008) | 418 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Negative DNA (Month 24 Post HPV-008) | 444 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Missing DNA (Month 24 Post HPV-008) | 7 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Positive DNA (Month 36 Post HPV-008) | 255 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Negative DNA (Month 36 Post HPV-008) | 236 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Missing DNA (Month 36 Post HPV-008) | 4 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Positive DNA (Month 48 Post HPV-008) | 144 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Negative DNA (Month 48 Post HPV-008) | 107 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) | Missing DNA (Month 48 Post HPV-008) | 7 Participants |
Primary
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Time frame: At Month 12
Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | Loop cone of cervix, Yes | 15 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | Loop cone of cervix, No | 17 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | Cold knife cone of cervix, No | 32 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | Treatment referral, Yes | 33 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | Treatment referral, No | 359 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | Loop excision of cervix, Yes | 14 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | Loop excision of cervix, No | 18 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | Cold knife cone of cervix, Yes | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | Laser excision, Yes | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | Laser excision, No | 31 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 12 | Other | 4 Participants |
Primary
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Time frame: At Month 24
Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Loop cone of cervix, Yes | 4 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Loop cone of cervix, No | 13 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Treatment referral, Yes | 19 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Treatment referral, No | 243 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Treatment referral, Missing | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Loop excision of cervix, Yes | 9 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Loop excision of cervix, No | 8 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Cold knife cone of cervix, Yes | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Cold knife cone of cervix, No | 16 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Laser excision, Yes | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Laser excision, No | 17 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 24 | Other | 4 Participants |
Primary
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Time frame: At Month 36
Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | Loop excision of cervix, Yes | 4 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | Loop cone of cervix, Yes | 4 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | Laser excision, No | 10 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | Other | 2 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | Treatment referral, Yes | 13 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | Treatment referral, No | 145 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | Loop excision of cervix, No | 6 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | Loop cone of cervix, No | 6 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | Cold knife cone of cervix, Yes | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | Cold knife cone of cervix, No | 10 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 36 | Laser excision, Yes | 0 Participants |
Primary
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Time frame: At Month 48
Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | Treatment referral, Yes | 9 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | Treatment referral, No \ | 87 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | Loop excision of cervix, Yes | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | Loop excision of cervix, No | 7 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | Loop cone of cervix, Yes | 5 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | Loop cone of cervix, No | 3 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | Cold knife cone of cervix, Yes | 0 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | Cold knife cone of cervix, No | 8 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | Laser excision, No | 7 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | Other | 1 Participants |
| HPV-052 Study Subjects Group | Number of Subjects With Treatment Referrals by Treatment Type at Month 48 | Laser excision, Yes | 1 Participants |