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The purpose of this prospective, multi-centre, PMS cohort study was to monitor the safety of Cervarix, which is the first HPV vaccine licensed for use in China, to help prevent cervical cancer caused by HPV types 16 and 18. The vaccine was approved by National Drug Administration of China (CNDA), in July 2016.
As per the CNDA commitment, this study collected data regarding the safety of the vaccine, related information on potential immune-mediated diseases (pIMDs); which are diseases that could affect the immune system, and the effect on pregnancy outcomes (POs) including birth defects in the newborn.
Cervarix was approved for use in females between 9-25 years of age, for the prevention of cervical cancer, cervical intraepithelial neoplasia grade 1 (CIN1), cervical intraepithelial neoplasia grade 2, grade 3 (CIN 2/3) and adenocarcinoma in situ caused by high-risk human papillomavirus (HR-HPV) types 16 and 18.
In May 2018, Cervarix was also approved for use in women of age up to 45 years.
The exposed set (ES) comprised 3013 subjects, who were vaccinated with Cervarix, on a voluntary basis, as per standard practice. The study collected information on any adverse event following immunisation, pIMDs, POs and congenital anomalies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix group | Healthy female Chinese subjects aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safety data collection (following routine vaccination) | Other | This study assessed the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine when administered routinely according to the Prescribing Information in female Chinese subjects aged between 9 and 45 years. The intervention consisted in the active surveillance of adverse events following immunization and pregnancy outcomes if the vaccine was administered inadvertently during pregnancy. Information of potential adverse events and pregnancy outcomes were collected at immunisation visits, telephone contacts and through spontaneous reporting by the patient/LAR/physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs) | An adverse event following immunisation (AEFI) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a vaccine. Medically attended AEFIs are defined as events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Any Medically attended AEFIS are presented for each dose and across doses. Grade 3 Medically attended AEFI = an AEFI which prevented normal, everyday activities. Related Medically Attended AEFI = AEFI assessed by the investigator as related to the vaccination. | During the 30-day period following each immunisation with Cervarix (administered on Day 1, Month 1 and Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any, Fatal and Vaccine Related Serious AEFIs (Across Doses) | Serious AEFIs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a participant. Any serious AEFI = If a medically attended AEFI led to hospitalisation (or met any other serious AEFI criteria). Fatal Serious AEFIs are those events that resulted in death. Related Serious AEFIs= AEFIs assessed by the investigator as causally related to the study vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
• Child in care
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Healthy female Chinese subjects aged between 9 and 45 years, vaccinated on a voluntary basis as per standard practice.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Foshan | Guangdong | 528000 | China | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38038626 | Derived | Wu Q, Qian M, Welby S, Guignard A, Rosillon D, Gopala K, Xu Y, Liu K, He Y, Jiang N, Tan Q, Xie J, Zhu T, Wang Q, Pan Y, Zeng R, Yang J, Zhao X, Zhou M, Navarro-Torne A, Yu H, Borys D. Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018-2020. Hum Vaccin Immunother. 2023 Dec 15;19(3):2283912. doi: 10.1080/21645515.2023.2283912. Epub 2023 Dec 1. |
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Out of 3016 participants enrolled in the study, 3 participants did not receive any vaccination and therefore were not included in any analysis.
The study was conducted at 8 centres in China
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2018 | Aug 11, 2021 |
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|
| Throughout the study period (From Day 1 to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24) whichever occured first)) |
| Number of Participants With Any, Grade 3 and Vaccine Related Potential Immune Mediated Diseases (pIMDs) (Across Doses) | pIMDs are a subset of AEFIs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology. Any was defined as the occurrence of any pIMD regardless of intensity grade or relation to vaccination. Grade 3 pIMDs = pIMDs which prevented normal, everyday activities. Related pIMDs = pIMDs assessed by the investigator as related to the vaccination. | Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first)) |
| Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies | The number of participants reporting pregnancies and outcomes of reported pregnancies (elective abortion for medical reasons, spontaneous abortion or congenital anomaly) when Cervarix was administered to the participant, inadvertently within 60 days before pregnancy onset, or any time during pregnancy, was reported. | Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first)) |
| Shenzhen |
| Guangdong |
| 518000 |
| China |
| GSK Investigational Site | Shenzhen | Guangdong | 518020 | China |
| GSK Investigational Site | Changzhou | Jiangsu | 213100 | China |
| GSK Investigational Site | Chengdu | Sichuan | 610000 | China |
| GSK Investigational Site | Shanghai | 200030 | China |
| GSK Investigational Site | Shanghai | 200136 | China |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs) | An adverse event following immunisation (AEFI) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a vaccine. Medically attended AEFIs are defined as events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Any Medically attended AEFIS are presented for each dose and across doses. Grade 3 Medically attended AEFI = an AEFI which prevented normal, everyday activities. Related Medically Attended AEFI = AEFI assessed by the investigator as related to the vaccination. | Analysis was based on the Exposed Set (ES) which included all participants exposed to Cervarix and who provided safety data. | Posted | Count of Participants | Participants | During the 30-day period following each immunisation with Cervarix (administered on Day 1, Month 1 and Month 6) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any, Fatal and Vaccine Related Serious AEFIs (Across Doses) | Serious AEFIs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a participant. Any serious AEFI = If a medically attended AEFI led to hospitalisation (or met any other serious AEFI criteria). Fatal Serious AEFIs are those events that resulted in death. Related Serious AEFIs= AEFIs assessed by the investigator as causally related to the study vaccination. | Analysis was based on the Exposed Set (ES) which included all participants exposed to Cervarix. | Posted | Count of Participants | Participants | Throughout the study period (From Day 1 to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24) whichever occured first)) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any, Grade 3 and Vaccine Related Potential Immune Mediated Diseases (pIMDs) (Across Doses) | pIMDs are a subset of AEFIs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology. Any was defined as the occurrence of any pIMD regardless of intensity grade or relation to vaccination. Grade 3 pIMDs = pIMDs which prevented normal, everyday activities. Related pIMDs = pIMDs assessed by the investigator as related to the vaccination. | Analysis was based on the Exposed Set (ES) which included all participants exposed to Cervarix. | Posted | Count of Participants | Participants | Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first)) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies | The number of participants reporting pregnancies and outcomes of reported pregnancies (elective abortion for medical reasons, spontaneous abortion or congenital anomaly) when Cervarix was administered to the participant, inadvertently within 60 days before pregnancy onset, or any time during pregnancy, was reported. | The analysis was based on the ES, which included all participants exposed to Cervarix and who reported pregnancies and/or outcomes of reported pregnancies. | Posted | Count of Participants | Participants | Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first)) |
|
|
Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervarix Group | Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice. | 0 | 3,013 | 22 | 3,013 | 143 | 3,013 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Glycogen storage disease type I | Congenital, familial and genetic disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Type V hyperlipidaemia | Congenital, familial and genetic disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Viral hepatitis carrier | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| High risk pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Uterine scar | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Conjunctival oedema | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Animal scratch | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neuritis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Breast hyperplasia | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Polymenorrhoea | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 4, 2020 | Aug 11, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
|
| Dose 3 |
|
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| Across doses |
|
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| Grade 3 |
|
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| Related |
|
|
|
|
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