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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS6521 | Registry Identifier | EU PAS Register |
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The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline (GSK) Biologicals' seasonal Inactivated Influenza Vaccines (sIIVs): Fluarix, FluLaval, Fluarix Quadrivalent and FluLaval Quadrivalent.
This study is a transition of existing ongoing pregnancy registries for Fluarix/ FluLaval/Fluarix Quadrivalent/ FluLaval Quadrivalent into one post-authorization safety study (PASS).
Pregnancy outcome data will be collected using questionnaires within 2 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births) to ascertain the presence of birth defects not diagnosed before, from Q2 2014 to Q2 2019.
The intent of the Registry is to prospectively collect data such as vaccination with GSK sIIVs during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed cohort | Pregnant women, vaccinated with any of the 4 GSK seasonal Inactivated Influenza Vaccine(s) (GSK sIIVs): Fluarix/ FluLaval/Fluarix Quadrivalent /FluLaval Quadrivalent during pregnancy or within 28 days preceding conception. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Initial and follow-up data was collected using questionnaires. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure, in Pregnant Women Intentionally or Unintentionally Vaccinated With FluLaval During Pregnancy or Within 28 Days Preceding Conception | Exposures and outcomes were stratified by trimester of exposure: first (1st), second (2nd), third (3rd) and unknown trimester (Tr?) multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated based on the date of the last menstrual period. The 2nd trimester was considered to begin at week 14 and the 3rd trimester begun at week 28. The presence or absence of birth defects or other abnormalities was evaluated within each of the preceding outcome categories. Ongoing = subject still pregnant at the time of last contact. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020. Unknown = unknown outcome at the time of last contact. | Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births) |
| Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With FluLaval Quadrivalent During Pregnancy or Within 28 Days Preceding Conception | Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Results were presented for the following categories: Ongoing, Live infants without congenital anomalies (Live infants without CA.); Spontaneous abortions with no apparent congenital anomalies (Sp. abortions with no ACA); Spontaneous abortions with congenital anomalies (Sp. abortions with CA). One subject had FluLaval Quadrivalent and Fluarix Quadrivalent listed as vaccine used. Therefore, same case was included in the respective table of each product in "Live infants without CA, 3rd Tr." category. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020. |
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Inclusion Criteria:
A subject will be included in the Registry if all of the following criteria are met:
Data from registered subjects will be included in the analyses if the following criterion is met:
• Pregnancy is ongoing and the outcome is unknown at the time of initial report.
Exclusion Criteria:
Data from registered subjects will not be included in the analyses if the following criterion is met:
• Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus.
Pregnant women
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Pregnant women, residing in the US, vaccinated with any of the 4 GSK sIIVs during pregnancy or within 28 days preceding conception and who are volunteering to take part in the Pregnancy Registry before the outcome of the pregnancy is known.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wilmington | North Carolina | 284013331 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34082643 | Derived | Nwoji U. Seasonal influenza vaccine exposure in pregnancy: 5-year results from a pregnancy registry. Hum Vaccin Immunother. 2022 Dec 31;18(1):1932213. doi: 10.1080/21645515.2021.1932213. Epub 2021 Jun 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exposed Group | Pregnant women, vaccinated with any of the 4 GSK seasonal Inactivated Influenza Vaccine(s) (GSK sIIVs): Fluarix/ FluLaval/Fluarix Quadrivalent /FluLaval Quadrivalent during pregnancy or within 28 days preceding conception. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exposure Group | Pregnant women, vaccinated with any of the 4 GSK seasonal Inactivated Influenza Vaccine(s) (GSK sIIVs): Fluarix/ FluLaval/Fluarix Quadrivalent /FluLaval Quadrivalent during pregnancy or within 28 days preceding conception. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age not specified = age unspecified in the Pregnancy Registry. Not applicable was defined as mother cases for which coding under the Pregnancy Registry was only about their infant. |
| 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 Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure, in Pregnant Women Intentionally or Unintentionally Vaccinated With FluLaval During Pregnancy or Within 28 Days Preceding Conception | Exposures and outcomes were stratified by trimester of exposure: first (1st), second (2nd), third (3rd) and unknown trimester (Tr?) multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated based on the date of the last menstrual period. The 2nd trimester was considered to begin at week 14 and the 3rd trimester begun at week 28. The presence or absence of birth defects or other abnormalities was evaluated within each of the preceding outcome categories. Ongoing = subject still pregnant at the time of last contact. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020. Unknown = unknown outcome at the time of last contact. | Analysis was performed on pregnant women vaccinated with FluLaval vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study and who completed the study period. | Posted | Count of Participants | Participants | Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births) |
Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
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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 | Exposure Group | Pregnant women, vaccinated with any of the 4 GSK seasonal Inactivated Influenza Vaccine(s) (GSK sIIVs): Fluarix/ FluLaval/Fluarix Quadrivalent /FluLaval Quadrivalent during pregnancy or within 28 days preceding conception. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cleft lip and palate | Congenital, familial and genetic disorders | MedDRA 22.0 | Systematic Assessment | This SAE is reported in infant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2017 | May 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births) |
| Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With Fluarix During Pregnancy or Within 28 Days Preceding Conception | Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Unknown = unknown outcome at the time of last contact. | Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births) |
| Number of Subjects Reported With Exposure and Outcomes Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With Fluarix Quadrivalent During Pregnancy or Within 28 Days Preceding Conception | Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Results were presented for the following categories: Ongoing, Live infants without CA; Live infants with CA; Sp. abortions with no ACA; Sp. abortions with CA; Stillbirth with no ACA. Unknown = unknown pregnancy outcome at the time of last contact. One subject had FluLaval Quadrivalent and Fluarix Quadrivalent listed as vaccine used. Therefore, same case was included in the respective table of each product in "Live infants without CA, 3rd Tr." category. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020. | Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births) |
| Number of Subjects Reported With Unsolicited Adverse Events (AEs) | 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 during the clinical study. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019 |
| Number of Subjects Reported With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019 |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
|
| Primary | Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With FluLaval Quadrivalent During Pregnancy or Within 28 Days Preceding Conception | Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Results were presented for the following categories: Ongoing, Live infants without congenital anomalies (Live infants without CA.); Spontaneous abortions with no apparent congenital anomalies (Sp. abortions with no ACA); Spontaneous abortions with congenital anomalies (Sp. abortions with CA). One subject had FluLaval Quadrivalent and Fluarix Quadrivalent listed as vaccine used. Therefore, same case was included in the respective table of each product in "Live infants without CA, 3rd Tr." category. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020. | Analysis was performed on pregnant women vaccinated with FluLaval Quadrivalent vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study, and who completed the study period. | Posted | Count of Participants | Participants | Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births) |
|
|
|
| Primary | Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With Fluarix During Pregnancy or Within 28 Days Preceding Conception | Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Unknown = unknown outcome at the time of last contact. | Analysis was performed on pregnant women vaccinated with Fluarix vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study, and who completed the study period. | Posted | Count of Participants | Participants | Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births) |
|
|
|
| Primary | Number of Subjects Reported With Exposure and Outcomes Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With Fluarix Quadrivalent During Pregnancy or Within 28 Days Preceding Conception | Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Results were presented for the following categories: Ongoing, Live infants without CA; Live infants with CA; Sp. abortions with no ACA; Sp. abortions with CA; Stillbirth with no ACA. Unknown = unknown pregnancy outcome at the time of last contact. One subject had FluLaval Quadrivalent and Fluarix Quadrivalent listed as vaccine used. Therefore, same case was included in the respective table of each product in "Live infants without CA, 3rd Tr." category. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020. | Analysis was performed on pregnant women vaccinated with Fluarix Quadrivalent vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study, and who completed the study period. | Posted | Count of Participants | Participants | Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births) |
|
|
|
| Primary | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | 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 during the clinical study. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | Analysis was performed on pregnant women vaccinated with GSK sIIV vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study. | Posted | Count of Participants | Participants | Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019 |
|
|
|
| Primary | Number of Subjects Reported With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Analysis was performed on pregnant women vaccinated with GSK sIIV vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study. | Posted | Count of Participants | Participants | Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019 |
|
|
|
| 2 |
| 507 |
| 9 |
| 507 |
| 507 |
| 507 |
|
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 22.0 | Systematic Assessment | This SAE is reported in infant. |
|
| Injection site cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
|
| Caesarean section | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Crying | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site edema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Multiple allergies | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Contraindicated product administered | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Expired product administered | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment | The inclusion of this in the AE table is a function of the coding convention of the medical coding system. |
|
| Exposure via body fluid | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Extra dose administered | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Maternal exposure before pregnancy | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment | The inclusion of this in the AE table is a function of the coding convention of the medical coding system. |
|
| Maternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment | The inclusion of this in the AE table is a function of the coding convention of the medical coding system. |
|
| Maternal exposure timing unspecified | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment | The inclusion of this in the AE table is a function of the coding convention of the medical coding system. |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Wrong product administered | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Wrong technique in product usage process | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Neuritis | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Arrested labor | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
|
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
|
| Live birth | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
|
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
|
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
|
| Prolonged pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
|
| Twin pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
|
| Umbilical cord around neck | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | 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.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Title | Measurements |
|---|---|
|
| Ongoing, Tr? |
|
| Live infants without CA, 1st Tr. |
|
| Live infants without CA, 2nd Tr. |
|
| Live infants without CA, 3rd Tr. |
|
| Live infants without CA, Tr? |
|
| Sp. abortions with no ACA, 1st Tr. |
|
| Sp. abortions with no ACA, 2nd Tr. |
|
| Sp. abortions with no ACA, 3rd Tr. |
|
| Sp. abortions with no ACA, Tr? |
|
| Sp. abortions with CA, 1st Tr. |
|
| Sp. abortions with CA, 2nd Tr. |
|
| Sp. abortions with CA, 3rd Tr. |
|
| Sp. abortions with CA, Tr? |
|
| Title | Measurements |
|---|---|
|
| Unknown, Tr? |
|
| Title | Measurements |
|---|---|
|
| Ongoing, Tr? |
|
| Live infants without CA, 1st Tr. |
|
| Live infants without CA, 2nd Tr. |
|
| Live infants without CA, 3rd Tr. |
|
| Live infants without CA, Tr? |
|
| Live infants with CA, 1st Tr. |
|
| Live infants with CA, 2nd Tr. |
|
| Live infants with CA, 3rd Tr. |
|
| Live infants with CA, Tr? |
|
| Sp. abortions with no ACA, 1st Tr. |
|
| Sp. abortions with no ACA, 2nd Tr. |
|
| Sp. abortions with no ACA, 3rd Tr. |
|
| Sp. abortions with no ACA, Tr? |
|
| Sp. abortions with CA, 1st Tr. |
|
| Sp. abortions with CA, 2nd Tr. |
|
| Sp. abortions with CA, 3rd Tr. |
|
| Sp. abortions with CA, Tr? |
|
| Stillbirth with no ACA, 1st Tr. |
|
| Stillbirth with no ACA, 2nd Tr. |
|
| Stillbirth with no ACA, 3rd Tr. |
|
| Stillbirth with no ACA, Tr? |
|
| Unknown, 1st Tr. |
|
| Unknown, 2nd Tr. |
|
| Unknown, 3rd Tr. |
|
| Unknown, Tr? |
|