| Primary | Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Referral to Colposcopy at Month 12 | Detection was done on all subjects irrespective of their baseline HPV DNA status. | 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. | Posted | | Count of Participants | | Participants | | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Referral to Colposcopy at Month 24 | Detection was done on all subjects irrespective of their baseline HPV DNA status. | 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. | Posted | | Count of Participants | | Participants | | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Referral to Colposcopy at Month 36 | Detection was done on all subjects irrespective of their baseline HPV DNA status. | 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. | Posted | | Count of Participants | | Participants | | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Referral to Colposcopy at Month 48 | Detection was done on all subjects irrespective of their baseline HPV DNA status. | 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. | Posted | | Count of Participants | | Participants | | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Referral to Treatment 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Referral to Treatment 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Referral to Treatment 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Number of Subjects With Referral to Treatment 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |