Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
---|---|---|---|---|---|---|
Fragoso a (control exposed to Glatiramer), 2013 |
Brazil Not specified |
Children born from mothers with MS. | The drug-exposure group was considered to be at least 2 weeks of Interferon beta-1a (addition of data of IFN-beta Avonex and IFN-beta Rebif) use at any time after conception. (This is a subgroup of exposure among the exposed group considered in the study). |
exposed to other treatment, sick
The drug-exposure group was considered to be at least 2 weeks of Glatiramer acetate use at any time after conception. (This is a subgroup of exposure among the exposed group considered in the study). |
29 / 39 | 'Patients who were receiving any other medication that might influence the results were excluded.' |
Fragoso a (control unexposed, sick), 2013 |
Brazil Not specified |
Children born from mothers with MS. | The drug-exposure group was considered to be at least 2 weeks of Interferon beta-1a (addition of data of IFN-beta Avonex and IFN-beta Rebif) use at any time after conception. (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, sick
The control group consisted of women with MS who were not exposed to any drugs for at least 3 months prior to conception and remained unexposed at all times during pregnancy. |
29 / 95 | 'Patients who were receiving any other medication that might influence the results were excluded.' |
Nguyen (control exposed to Glatiramer), 2019 |
International 2005 - 2016 |
Women of child-bearing age (15–45 years inclusive), prospectively enrolled in MSBase with a diagnosis of relapsing-remitting MS (RRMS). | Pregnancies occurring during Interferon beta1a (im and sc) therapy. (This is a subgroup of exposure among the exposed group considered in the study). |
exposed to other treatment, sick
Pregnancies occurring during Glatiramer acetate therapy. (This is a subgroup of exposure among the exposed group considered in the study). |
289 / 137 | Addition of IFNβ−1a i.m and IFNβ−1a s.c. |
Nguyen (control unexposed, sick), 2019 |
International 2005 - 2016 |
Women of child-bearing age (15–45 years inclusive), prospectively enrolled in MSBase with a diagnosis of relapsing-remitting MS (RRMS). | Pregnancies occurring during Interferon beta1a (im and sc) therapy. (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, sick
Pregnancies not exposed to disease-modifying therapies (DMTs) (pregnancy occurring within a year of DMT discontinuation or without DMT exposure in the prior year). |
289 / 886 | Addition of IFNβ−1a i.m and IFNβ−1a s.c. |
Weber-Schoendorfer (control exposed to Glatiramer), 2009 |
Germany 1996 - 2007 |
Pregnant women or their physicians who called the service for risk assessment in regard to exposure to medicines during pregnancy. | Women exposed groups to Interferon-β1a during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
exposed to other treatment, sick
Women exposed groups to Glatiramer acetate during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
48 / 31 | 'The main point of interest was the rate of major birth defects' |
Weber-Schoendorfer (control unexposed, disease free), 2009 |
Germany 1996 - 2007 |
Pregnant women or their physicians who called the service for risk assessment in regard to exposure to medicines during pregnancy. | Women exposed groups to Interferon-β1a during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, disease free
Pregnant women who had been counseled during pregnancy after exposures known to be nonteratogenic. |
48 / 1556 | 'The main point of interest was the rate of major birth defects' |
Weber-Schoendorfer (control unexposed, sick), 2009 |
Germany 1996 - 2007 |
Pregnant women or their physicians who called the service for risk assessment in regard to exposure to medicines during pregnancy. | Women exposed groups to Interferon-β1a during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). |
unexposed, sick
Multiple sclerosis patients who neither had taken the immunomodulatory drugs under study nor were exposed to known teratogens such as classical anticonvulsants or phenprocoumon, although some members of this group were given glucocorticoids for a relapse. |
48 / 64 | 'The main point of interest was the rate of major birth defects' |
Study | Country Study period |
Case | Control | Sample size | Rmk |
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