| Primary | Number of Lactating Women With Serum IgG Antibodies to Laronidase | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. | Posted | | Count of Participants | | Participants | | Up to 18 months | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. Mothers received commercially available laronidase as per the country labeling information at the study site. |
| | | Title | Denominators | Categories |
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| Primary | Amount of IgG Antibody Titers to Laronidase in Lactating Women | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase | Posted | | Mean | Standard Deviation | antibody titer | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Number of Women Who Breastfed | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. | Posted | | Count of Participants | | Participants | | Up to 18 months | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Number of Women Who Were Successful at Breastfeeding | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. | Posted | | Count of Participants | | Participants | | Up to 18 months | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Number of Women Whose Breast Milk Contains Laronidase | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. | Posted | | Count of Participants | | Participants | | Up to 18 months | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Amount of Laronidase in the Breast Milk of Lactating Mothers With Mucopolysaccharidosis I (MPS I) Disease | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. There were no women whose breast milk contained laronidase hence overall number of participants analyzed is zero. | Posted | | | | | | Up to 18 months | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Number of Women With Abnormal Urine Glycosaminoglycans (uGAG) Levels | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. | Posted | | Count of Participants | | Participants | | Up to 18 months | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Amount of uGAG in the Urine of Women | Urine samples were collected at specified intervals to measure uGAG in the urine of women. Reference range of uGAG between 2.64 - 37.65 was considered as normal. mg/g creatinine = milligram per gram of creatinine. | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. | Posted | | Mean | Standard Deviation | mg/g creatinine | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Number of Participants With Medical History of the Mother: Pre-Existing Conditions | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Physical Examination Findings of the Mother | Physical examination was performed at specified intervals. Physical examination included the following physical observations: general appearance, skin, head, ears, eyes, nose, and throat, lymph nodes, abdomen, extremities/joints, neurological, mental status, and the following, if appropriate, breasts, external genitalia, pelvic, and rectal. | Based on the low enrolment numbers, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | | | | | | Up to 18 months | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Temperature of the Mother | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. Temperature was not measured at Week 12. | Posted | | Mean | Standard Deviation | Celsius | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Heart Rate of the Mother | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. Heart rate was not measured at Week 12. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Respiratory Rate of the Mother | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. Respiratory rate was not measured at Baseline and Week 12. | Posted | | | | | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Blood Pressure of the Mother | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at specified timepoints. | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. Blood pressure was not measured at Week 12. | Posted | | Mean | Standard Deviation | millimeters of mercury | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Weight of the Mother | | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. | Posted | | Mean | Standard Deviation | kilograms | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Height of the Mother | | Based on the low enrolment numbers, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | | | | | | Baseline | | | | ID | Title | Description |
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| OG000 | Laronidase | Mothers treated with laronidase who intended to breastfeed their infants while receiving laronidase. |
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| Primary | Number of Infants With Abnormal uGAG Levels | | Infants who were breastfeed while the mothers were receiving laronidase. | Posted | | Count of Participants | | Participants | | Up to 72 weeks | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
| | | Title | Denominators | Categories |
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| Primary | Amount of uGAG in the Urine of Infants | Urine samples were collected at specified intervals to measure uGAG in the urine of infant. Reference range of uGAG between 30 - 300 was considered as normal. | Infants who were breastfeed while the mothers were receiving laronidase. No sample was collected at Week 60. | Posted | | Mean | Standard Deviation | mg/g creatinine | | Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, and Week 72 | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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| Primary | Number of Participants With Medical History of the Infant:Pre-Existing Conditions | | Infants who were breastfeed while the mothers were receiving laronidase. | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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| Primary | Number of Infants With Abnormal Physical Finding | Physical examination included the following physical observations: general appearance, skin, lymph nodes, heart, lungs, abdomen, extremities/joints, neurological, mental status, breasts, external genitalia, pelvic, rectal, and Heent. | Infants who were breastfeed while the mothers were receiving laronidase. | Posted | | Number | | participants | | Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72 | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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| Primary | Heart Rate of the Infant | Heart rate was measured at specified timepoints. | Infants who were breastfeed while the mothers were receiving laronidase. Heart rate was not measured at Baseline and Week 24. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72 | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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| Primary | Respiratory Rate of the Infant | Respiratory rate was measured at specified timepoints. | Infants who were breastfeed while the mothers were receiving laronidase. Respiratory rate was not measured at Baseline and Week 24. | Posted | | Mean | Standard Deviation | breaths/min | | Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72 | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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| Primary | Blood Pressure of the Infant | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at specified timepoints. | Infants who were breastfeed while the mothers were receiving laronidase. Blood pressure was not measured at Baseline, Week 12, and Week 24. | Posted | | Mean | Standard Deviation | millimeters of mercury | | Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72 | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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| Primary | Weight of the Infant | | Infants who were breastfeed while the mothers were receiving laronidase. | Posted | | Mean | Standard Deviation | kilograms | | Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72 | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
| | | Title | Denominators | Categories |
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| Primary | Height of the Infant | | Infants who were breastfeed while the mothers were receiving laronidase. | Posted | | Mean | Standard Deviation | centimeter | | Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72 | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
| | | Title | Denominators | Categories |
|---|
|
| Primary | Temperature of the Infant | | Infants who were breastfeed while the mothers were receiving laronidase. Temperature was not measured at Baseline and Week 12. | Posted | | Mean | Standard Deviation | Celcius | | Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72 | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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| Primary | Head Circumference of the Infant | | Infants who were breastfeed while the mothers were receiving laronidase. | Posted | | Mean | Standard Deviation | centimeter | | Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72 | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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| Primary | Number of Participants With Normal Overall Assessment Measured Using Denver II Developmental Screening Scores | Infant development was assessed with the Denver II Developmental Screening Test. It consisted of 5 areas/subscore i.e., test behavior, personal-social, fine motor, language, and gross motor. The number of participants with normal overall assessment measured using Denver II Developmental Screening Scores have been reported by visit. | Infants who were breastfeed while the mothers were receiving laronidase. | Posted | | Count of Participants | | Participants | | Week 12, Week 24, Week 36, Week 48, and Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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| Primary | Number of Infants With IgM and IgG Antibodies to Laronidase Present at Any Time Point | | Infants who were breastfeed while the mothers were receiving laronidase. | Posted | | Count of Participants | | Participants | | Baseline, Week 12, Week 24, Week 36, and Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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| Primary | Time to Development of IgM and IgG Antibodies to Laronidase | | Infants who were breastfeed while the mothers were receiving laronidase. No IgM and IgG antibody was detected during the study, hence time is not-evaluable. | Posted | | | | | | up to Week 72 | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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| Primary | Amount of IgG and IgM Antibody Titers to Laronidase | | Infants who were breastfeed while the mothers were receiving laronidase. No IgG antibody was detected at Week 12, Week 24, Week 36, and Week 72. No IgM was detected at Baseline, Week 12, Week 24, Week 36, and Week 72. | Posted | | Mean | Standard Deviation | antibody titer | | Baseline, Week 12, Week 24, Week 36, and Week 72 | | | | ID | Title | Description |
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| OG000 | Laronidase | Infants who were breastfeed while the mothers were receiving laronidase. |
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