Trial Outcomes & Findings for Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes (NCT NCT03377699)
NCT ID: NCT03377699
Last Updated: 2023-01-20
Results Overview
Mean of the HbA1c data collected at gestational week (GW) corresponding to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. On-treatment observation period started at the date of first dose of trial product and ended at the date of the last day on trial product, up to 22 months.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
225 participants
Primary outcome timeframe
From GW 16 to GW 36
Results posted on
2023-01-20
Participant Flow
The trial was conducted at 56 sites in 14 countries as follows (number of sites that screened participants/number of sites that randomised participants):Argentina (5/4); Australia (7/7); Austria (3/3); Brazil (6/6); Canada (6/5); Croatia (1/1); Denmark (2/2); Greece (3/3); Ireland (2/2); Israel (2/2); Italy (5/5); Russian Federation (8/8); Serbia (2/2) and United Kingdom (8/6).
Based on participant pregnancy status, either non-pregnant with the intention to become pregnant or pregnant from gestational Week (GW) 8-13 + 6 days were randomised in a 1:1 ratio to receive either Insulin Degludec (IDeg) or Insulin Detemir (IDet) in combination with Insulin Aspart (IAsp) as subcutaneous injection.
Participant milestones
| Measure |
IDeg
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
114
|
|
Overall Study
Treated
|
110
|
112
|
|
Overall Study
SASpregnant
|
91
|
94
|
|
Overall Study
FASpregnant
|
92
|
96
|
|
Overall Study
COMPLETED
|
89
|
89
|
|
Overall Study
NOT COMPLETED
|
22
|
25
|
Reasons for withdrawal
| Measure |
IDeg
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
9
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Commencement of medical infertility treatment during the course of the trial
|
1
|
0
|
|
Overall Study
Non-pregnant subject initiating medication contraindicated during pregnancy
|
1
|
1
|
|
Overall Study
Randomised non-pregnant did not become pregnant and withdrawn from trial
|
11
|
8
|
|
Overall Study
Randomised non-pregnant did not become pregnant and NOT withdrawn from trial
|
6
|
6
|
Baseline Characteristics
Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
IDeg
n=111 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=114 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.2 Years
STANDARD_DEVIATION 5.20 • n=99 Participants
|
31.1 Years
STANDARD_DEVIATION 5.28 • n=107 Participants
|
31.2 Years
STANDARD_DEVIATION 5.23 • n=206 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
225 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From GW 16 to GW 36Population: FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = participants with available data.
Mean of the HbA1c data collected at gestational week (GW) corresponding to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. On-treatment observation period started at the date of first dose of trial product and ended at the date of the last day on trial product, up to 22 months.
Outcome measures
| Measure |
IDeg
n=84 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=84 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery
in-trial
|
6.30 Percentage glycosylated hemoglobin
Standard Deviation 0.70
|
6.26 Percentage glycosylated hemoglobin
Standard Deviation 0.73
|
|
Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery
on-treatment
|
6.32 Percentage glycosylated hemoglobin
Standard Deviation 0.69
|
6.26 Percentage glycosylated hemoglobin
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: From GW 16 to GW 36Population: FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.
Number of participants who achieved pre-defined HbA1c targets ≤ 6.0% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.0% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.0% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Outcome measures
| Measure |
IDeg
n=84 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=84 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants With HbA1c Below or Equal to 6.0% [42 Millimoles Per Mole (mmol/Mol)] From Last Planned HbA1c Prior to Delivery (Yes/no)
No
|
48 Participants
|
53 Participants
|
|
Number of Participants With HbA1c Below or Equal to 6.0% [42 Millimoles Per Mole (mmol/Mol)] From Last Planned HbA1c Prior to Delivery (Yes/no)
Yes
|
36 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: From GW 16 to GW 36Population: FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.
Number of participants who achieved pre-defined HbA1c targets ≤ 6.5% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.5% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.5% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Outcome measures
| Measure |
IDeg
n=84 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=84 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no)
No
|
26 Participants
|
31 Participants
|
|
Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no)
Yes
|
58 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: From GW 16 to GW 36Population: FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.
Mean of post-prandial glucose (PPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. Average PPG is defined as the average of the available blood glucouse (BG) measurements 90 minutes after breakfast, lunch and main evening meal respectively. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Outcome measures
| Measure |
IDeg
n=75 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=72 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals)
|
7.37 mmol/L
Standard Deviation 1.35
|
6.96 mmol/L
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: From GW 16 to GW 36Population: FASpregnant which included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.
Mean of fasting plasma glucose (FPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from in-trial observation period. The in-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Outcome measures
| Measure |
IDeg
n=82 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=83 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Last Planned Fasting Plasma Glucose Prior to Delivery
|
6.17 mmol/L
Standard Deviation 2.05
|
6.79 mmol/L
Standard Deviation 2.47
|
SECONDARY outcome
Timeframe: From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)Population: SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.
Number of treatment emergent hypoglycaemic episodes during the pregnancy period is presented. Hypoglycaemic episode (plasma glucose \<= 3.9 mmol/L (70 milligrams per decilitre (mg/dL)) Or \> 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs on or after the first day of trial product administration, and no later than 7 days from the last day on trial product. The endpoint was evaluated based on the data from pregnancy period. Pregnancy period started from first day of pregnancy (date of conception corresponding to the first day in GW 2) or randomisation (whichever comes last) to the date of delivery.
Outcome measures
| Measure |
IDeg
n=91 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=94 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Hypoglycaemic Episodes During the Pregnancy Period
|
5431 Episodes
|
5982 Episodes
|
SECONDARY outcome
Timeframe: From pregnancy baseline (corresponding to GW 8-13) to end of treatment (28 days after delivery)Population: SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial
Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. Eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between pregnancy baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy.
Outcome measures
| Measure |
IDeg
n=91 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=94 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)
Left eye · No
|
79 Participants
|
79 Participants
|
|
Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)
Left eye · Missing
|
10 Participants
|
13 Participants
|
|
Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)
Right eye · Yes
|
2 Participants
|
2 Participants
|
|
Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)
Right eye · No
|
79 Participants
|
79 Participants
|
|
Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)
Right eye · Missing
|
10 Participants
|
13 Participants
|
|
Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)
Left eye · Yes
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From treatment baseline (week 0) to end of treatment (28 days after delivery)Population: SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.
Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. For pregnant women, eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between treatment baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy.
Outcome measures
| Measure |
IDeg
n=91 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=94 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)
Right eye · Yes
|
2 Participants
|
2 Participants
|
|
Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)
Right eye · Missing
|
10 Participants
|
13 Participants
|
|
Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)
Left eye · No
|
79 Participants
|
79 Participants
|
|
Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)
Left eye · Missing
|
10 Participants
|
13 Participants
|
|
Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)
Right eye · No
|
79 Participants
|
79 Participants
|
|
Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)
Left eye · Yes
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)Population: SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.
Number of adverse events (AEs) during pregnancy period is reported. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs presented are treatment-emergent AEs (TEAEs). The TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Outcome measures
| Measure |
IDeg
n=91 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=94 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Adverse Events During Pregnancy Period
|
429 Events
|
328 Events
|
SECONDARY outcome
Timeframe: From GW 20 to deliveryPopulation: SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.
Number of participants with one or more events of pre-eclampsia during pregnancy period is reported. Pre-eclampsia was defined as new-onset hypertension (greater than or equal to) ≥ 140 millimeters of mercury (mmHg) systolic or ≥ 90 mmHg diastolic, based on at least 2 measurements taken at least 4 hours apart) occurring from GW 20 to delivery and simultaneous proteinuria (defined as ≥ 300 mg protein in a 24 hours urine sample, a protein-to-creatinine ratio of ≥ 300 mg/g in a urine sample or a urine dipstick protein of 1+) or presence of eclampsia, haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome, or other severe organ involvement. In the reported data, 'Yes' infers number of participants who had pre-eclampsia events whereas 'No' infers number of participants who have not had pre-eclampsia events.
Outcome measures
| Measure |
IDeg
n=91 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=94 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants With Pre-eclampsia Defined as New-onset Hypertension Occurring From Gestational Week 20 to Delivery and Simultaneous Proteinuria or Presence of Eclampsia, HELLP Syndrome, or Other Severe Organ Involvement (Yes/no)
Yes
|
12 Participants
|
7 Participants
|
|
Number of Participants With Pre-eclampsia Defined as New-onset Hypertension Occurring From Gestational Week 20 to Delivery and Simultaneous Proteinuria or Presence of Eclampsia, HELLP Syndrome, or Other Severe Organ Involvement (Yes/no)
No
|
79 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: At birthPopulation: SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.
Number of participants who had delivered by which mode of delivery (vaginal, operative vaginal, planned caesarean section or unplanned caesarean section delivery) is presented. Planned caesarean section: decision taken \> 8 hours prior to delivery. Unplanned caesarean section: decision taken ≤ 8 hours prior to delivery. In case of 'early foetal death' or if the participant did not fill the pregnancy outcome form then mode of delivery was reported as 'missing'.
Outcome measures
| Measure |
IDeg
n=91 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=94 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery
Spontaneous vaginal birth
|
11 Participants
|
18 Participants
|
|
Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery
Planned caesarean section
|
42 Participants
|
45 Participants
|
|
Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery
Operative vaginal birth
|
8 Participants
|
9 Participants
|
|
Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery
Missing
|
7 Participants
|
7 Participants
|
|
Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery
Non planned caesarean section
|
23 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From pregnancy baseline (corresponding to gestational week 8-13) to last planned visit before delivery (last weight recording before given birth)Population: SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial. Overall Number of Participants Analyzed = participants with available data.
Change in body weight from pregnancy baseline to last planned visit prior to delivery is presented.
Outcome measures
| Measure |
IDeg
n=85 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=84 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery
|
11.97 Kilogram (Kg)
Standard Deviation 4.79
|
10.81 Kilogram (Kg)
Standard Deviation 4.55
|
SECONDARY outcome
Timeframe: At birthPopulation: Infants who were born to FASpregnant women are included. FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
Mean birth weight for live birth infants is presented. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Outcome measures
| Measure |
IDeg
n=86 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=84 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Birth Weight for Live Birth Infants
|
3691.0 grams (g)
Standard Deviation 628.01
|
3490.2 grams (g)
Standard Deviation 629.94
|
SECONDARY outcome
Timeframe: At birthPopulation: Infants who were born to FASpregnant women are included. FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
Mean of birth weight SD score for live infants is presented. Birth weight SD score indicates how far an infant's score deviates from the mean of the reference population of same age and same sex born at the same gestational week as per local normal curves. The SD score of 0 indicates that the infants born weigh approximately the same, negative score indicates that the infants born weigh lesser and positive score indicates that the infants born weigh more when compared with the reference population. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Outcome measures
| Measure |
IDeg
n=66 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=59 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Birth Weight Standard Deviation (SD) Score for Live Birth Infants
|
1.7 Standard Deviation score
Standard Deviation 1.20
|
1.2 Standard Deviation score
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: At birthPopulation: Infants who were born to FASpregnant women are included. FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
Number of live born infants with birth weight \<10th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants.In the reported data,'Yes' infers number of live born infants with birth weight \<10th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not \<10th percentile for gestational age and sex.Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form.Endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion,up to 24 months.Date of trial completion:final scheduled follow-up visit (delivery + 58 days).
Outcome measures
| Measure |
IDeg
n=86 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=85 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no)
Yes
|
1 Participants
|
3 Participants
|
|
Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no)
No
|
84 Participants
|
81 Participants
|
|
Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no)
Unaddressed
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At birthPopulation: Infants who were born to FASpregnant women are included. FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
Number of live born infants with birth weight \>90th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants. In the reported data,'Yes' infers number of live born infants with birth weight \>90th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not \>90th percentile for gestational age and sex.Unaddressed category refers to cases where either parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if THE participants did not fill the pregnancy outcome form.The endpoint was evaluated based on the data from in-trial observation period:started at randomization and ended at the date of trial completion,up to 24 months. Date of trial completion:final scheduled follow-up visit (delivery + 58 days).
Outcome measures
| Measure |
IDeg
n=86 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=85 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no]
Yes
|
55 Participants
|
43 Participants
|
|
Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no]
No
|
30 Participants
|
41 Participants
|
|
Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no]
Unaddressed
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At birthPopulation: FASpregnant included all randomised women who were pregnant during the trial.
Number of pregnant women who had pre-term delivery is presented. Pre-term delivery refers to delivery in \< 37 completed GWs. In the reported data, 'Yes' infers number of participants who had pre-term delivery whereas 'No' infers number of participants who has not had pre-term delivery. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion,up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery+58 days). For participants who had not attended the follow-up visit,the date of trial completion was the date of the last participant-investigator contact.
Outcome measures
| Measure |
IDeg
n=92 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=96 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants With Pre-term Delivery
Yes
|
34 Participants
|
26 Participants
|
|
Number of Participants With Pre-term Delivery
No
|
57 Participants
|
66 Participants
|
|
Number of Participants With Pre-term Delivery
Unaddressed
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At birthPopulation: FASpregnant included all randomised women who were pregnant during the trial.
Number of participants who had early foetal death (delivery before 20 completed GWs) is presented. In the reported data, 'Yes' infers early foetal deaths whereas 'No' infers no foetal deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Outcome measures
| Measure |
IDeg
n=92 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=96 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no)
Yes
|
4 Participants
|
5 Participants
|
|
Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no)
No
|
87 Participants
|
87 Participants
|
|
Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no)
Unaddressed
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Between at least 20 completed GWs before delivery and before 7 completed days after deliveryPopulation: FASpregnant included all randomised women who were pregnant during the trial.
Number of participants who had foetal/infant loss at delivery is presented. Perinatal mortality: death of foetus/infant between ≥ 20 completed GWs before delivery and \<1 completed week after delivery). In the reported data, 'Yes' infers early foetal/infant deaths whereas 'No' infers no foetal/infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion, up to 24 months. Date of trial completion: final scheduled follow-up visit (delivery + 58 days).
Outcome measures
| Measure |
IDeg
n=92 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=96 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no)
Unaddressed
|
1 Participants
|
4 Participants
|
|
Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no)
Yes
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no)
No
|
91 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Between at least 7 completed days after delivery and before 28 completed days after deliveryPopulation: FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = participants with available data.
Number of participants who had infant loss after delivery is presented. Neonatal mortality: death of infant between ≥7 completed days after delivery and \< 28 completed days after delivery. In the reported data, 'Yes' infers infant deaths whereas 'No' infers no infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Outcome measures
| Measure |
IDeg
n=92 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=96 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no)
Yes
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no)
No
|
91 Participants
|
92 Participants
|
|
Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no)
Unaddressed
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At birthPopulation: FASpregnant included all randomised women who were pregnant during the trial.
Number of participants who delivered foetuses/infants with abnormalities (classified according to EUROCAT) is presented. Presence of major abnormalities were based on adjudicated data, as after adjudication congenital anomalies were classified into major or minor anomalies or in other categories. In reported data, 'Yes' infers presence of major abnormalities whereas 'No' infers absence of major abnormalities in foetus/infant. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion up to 24 months. Date of trial completion : final scheduled follow-up visit (delivery + 58 days).
Outcome measures
| Measure |
IDeg
n=92 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=96 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants With Presence of Major Abnormalities (Classified According to European Concerted Action on Congenital Anomalies and Twins (EUROCAT)) in Their Foetus/Infants
Yes
|
8 Participants
|
8 Participants
|
|
Number of Participants With Presence of Major Abnormalities (Classified According to European Concerted Action on Congenital Anomalies and Twins (EUROCAT)) in Their Foetus/Infants
No
|
84 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: At birthPopulation: FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = participants with available data.
Number of participants with live born infants is presented. In the reported data, 'Yes' infers number of live infants whereas 'No' infers early foetal death or termination of pregnancy (induced/elective abortion). The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Outcome measures
| Measure |
IDeg
n=92 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=96 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Participants With Live Born Infants (Yes/no)
Yes
|
86 Participants
|
85 Participants
|
|
Number of Participants With Live Born Infants (Yes/no)
No
|
5 Participants
|
7 Participants
|
|
Number of Participants With Live Born Infants (Yes/no)
Unaddressed
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From delivery to final follow-up 30 days after deliveryPopulation: Infants who were born to SASpregnant women are included. SASpregnant were randomised women exposed to at least one dose of trial product and who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AEs in foetus/infant with particular focus on the AEs from delivery to follow-up are presented.
Outcome measures
| Measure |
IDeg
n=91 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=94 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Number of Adverse Events in the Infant
|
164 Events
|
150 Events
|
SECONDARY outcome
Timeframe: During between 24 and 48 hours after birthPopulation: Infants who were born to FASpregnant women are included. FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
Number of infants with neonatal hypoglycaemic episodes is presented. Neonatal hypoglycaemic episodes defined as plasma glucose ≤ 1.7 mmol/L (31 mg/dL) during the first 24 hours after birth or below or equal to 2.5 mmol/L (45 mg/dl) between 24 hours and 48 hours after birth. In the reported data, 'Yes' infers number of infants with neonatal hypoglycaemic episodes whereas 'No' infers number of infants with no neonatal hypoglycaemic episodes. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form.
Outcome measures
| Measure |
IDeg
n=86 Participants
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=85 Participants
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|
|
Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)
During the first 24 hours after birth · Yes
|
20 Participants
|
19 Participants
|
|
Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)
Between 24 hours and 48 hours after birth · Yes
|
4 Participants
|
5 Participants
|
|
Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)
During the first 24 hours after birth · No
|
64 Participants
|
65 Participants
|
|
Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)
During the first 24 hours after birth · Unaddressed category
|
2 Participants
|
1 Participants
|
|
Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)
Between 24 hours and 48 hours after birth · No
|
77 Participants
|
78 Participants
|
|
Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)
Between 24 hours and 48 hours after birth · Unaddressed category
|
5 Participants
|
2 Participants
|
Adverse Events
IDeg
Serious events: 38 serious events
Other events: 76 other events
Deaths: 0 deaths
IDet
Serious events: 33 serious events
Other events: 61 other events
Deaths: 0 deaths
IDegInf
Serious events: 37 serious events
Other events: 17 other events
Deaths: 4 deaths
IDetInf
Serious events: 42 serious events
Other events: 20 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
IDeg
n=110 participants at risk
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=112 participants at risk
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDegInf
n=91 participants at risk
Infants born to the participants who received the following treatment were included in this arm: Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDetInf
n=94 participants at risk
Infants born to the participants who received the following treatment were included in this arm: Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
2/110 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
2.1%
2/94 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
2.1%
2/94 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
2.7%
3/110 • Number of events 3 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.8%
2/112 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Blood and lymphatic system disorders
Anaemia of pregnancy
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.8%
2/112 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic gestation
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
2.2%
2/91 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Investigations
Blood glucose increased
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Investigations
Blood ketone body increased
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Cervical incompetence
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Hepatobiliary disorders
Cholestasis of pregnancy
|
1.8%
2/110 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.8%
2/110 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.8%
2/112 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Surgical and medical procedures
Diabetes mellitus management
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Eye disorders
Diabetic retinal oedema
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Eclampsia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal hypokinesia
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Gastroenteritis
|
0.91%
1/110 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
2.7%
3/110 • Number of events 3 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
5.4%
6/112 • Number of events 6 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational oedema
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
HELLP syndrome
|
2.7%
3/110 • Number of events 3 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Nervous system disorders
Headache
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Vascular disorders
Hypertension
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.6%
4/110 • Number of events 7 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
5.4%
6/112 • Number of events 7 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Eye disorders
Macular oedema
|
0.91%
1/110 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Surgical and medical procedures
Maternal therapy to enhance foetal lung maturity
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Investigations
Medical observation
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Placental insufficiency
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Polyhydramnios
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
1.8%
2/110 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
5.5%
6/110 • Number of events 6 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.8%
2/112 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Nervous system disorders
Sciatica
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Reproductive system and breast disorders
Shortened cervix
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Threatened labour
|
1.8%
2/110 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
3.6%
4/112 • Number of events 5 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine contractions abnormal
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Reproductive system and breast disorders
Uterine haematoma
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine hypotonus
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.91%
1/110 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
2/110 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
ABO haemolytic disease of newborn
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Ankyloglossia congenital
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
3.2%
3/94 • Number of events 3 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
2.2%
2/91 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
2.1%
2/94 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Investigations
Cardiac murmur
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Cephalhaematoma
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Congenital naevus
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Congenital pneumonia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Congenital pyelocaliectasis
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
External auditory canal atresia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
4.4%
4/91 • Number of events 4 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
3.2%
3/94 • Number of events 3 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Injury, poisoning and procedural complications
Fracture of clavicle due to birth trauma
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Haemangioma congenital
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
2.1%
2/94 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Metabolism and nutrition disorders
Hypoglycaemia neonatal
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
5.5%
5/91 • Number of events 5 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
4.3%
4/94 • Number of events 4 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Immature respiratory system
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
5.3%
5/94 • Number of events 5 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Kidney duplex
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Eye disorders
Lacrimal mucocoele
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Microtia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Metabolism and nutrition disorders
Neonatal hypocalcaemia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
2.1%
2/94 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
9.9%
9/91 • Number of events 9 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal tachypnoea
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Newborn persistent pulmonary hypertension
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Metabolism and nutrition disorders
Poor feeding infant
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Poor weight gain neonatal
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
9.9%
9/91 • Number of events 9 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
3.2%
3/94 • Number of events 3 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
3.2%
3/94 • Number of events 3 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Sepsis
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
5.5%
5/91 • Number of events 5 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Shoulder dystocia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Systemic bacterial infection
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Transient tachypnoea of the newborn
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
3.3%
3/91 • Number of events 3 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
2.1%
2/94 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
3.2%
3/94 • Number of events 3 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Weight decrease neonatal
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Anencephaly
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Bladder agenesis
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Enteric duplication
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Foetal malformation
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 3 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Polydactyly
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Congenital, familial and genetic disorders
Renal aplasia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Investigations
Ultrasound foetal abnormal
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
Other adverse events
| Measure |
IDeg
n=110 participants at risk
Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDet
n=112 participants at risk
Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDegInf
n=91 participants at risk
Infants born to the participants who received the following treatment were included in this arm: Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) \<3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) \>15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
IDetInf
n=94 participants at risk
Infants born to the participants who received the following treatment were included in this arm: Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: \<3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and \>15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
6/110 • Number of events 9 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
2.2%
2/91 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
2/110 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
5.4%
6/112 • Number of events 8 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
22/110 • Number of events 22 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
14.3%
16/112 • Number of events 16 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
8/110 • Number of events 9 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/94 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Nervous system disorders
Headache
|
7.3%
8/110 • Number of events 18 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
8.9%
10/112 • Number of events 16 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Influenza
|
4.5%
5/110 • Number of events 6 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
6.2%
7/112 • Number of events 10 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Nasopharyngitis
|
19.1%
21/110 • Number of events 30 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
20.5%
23/112 • Number of events 45 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Gastrointestinal disorders
Nausea
|
6.4%
7/110 • Number of events 7 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
6.2%
7/112 • Number of events 10 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
General disorders
Oedema peripheral
|
7.3%
8/110 • Number of events 9 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.89%
1/112 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.5%
5/110 • Number of events 5 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
6.2%
7/112 • Number of events 10 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Pharyngitis
|
6.4%
7/110 • Number of events 7 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.8%
2/112 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Placental insufficiency
|
6.4%
7/110 • Number of events 7 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
4.5%
5/112 • Number of events 5 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Polyhydramnios
|
5.5%
6/110 • Number of events 6 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
7.1%
8/112 • Number of events 8 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
3.6%
4/110 • Number of events 4 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
5.4%
6/112 • Number of events 7 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Renal and urinary disorders
Proteinuria
|
5.5%
6/110 • Number of events 7 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
3.6%
4/112 • Number of events 4 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Sinusitis
|
1.8%
2/110 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
5.4%
6/112 • Number of events 6 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
11/110 • Number of events 16 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
8.0%
9/112 • Number of events 11 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
6.4%
7/110 • Number of events 12 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
4.5%
5/112 • Number of events 5 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/91 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
8/110 • Number of events 8 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
5.4%
6/112 • Number of events 8 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
1.1%
1/91 • Number of events 1 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/94 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
2.2%
2/91 • Number of events 2 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
7.4%
7/94 • Number of events 8 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
6.6%
6/91 • Number of events 8 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
8.5%
8/94 • Number of events 8 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/110 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
0.00%
0/112 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
5.5%
5/91 • Number of events 5 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
5.3%
5/94 • Number of events 5 • For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
|
Additional Information
Clinical Transparency Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER