Pregnancy in the Clinical Study. Women of childbearing potential or women who are pregnant at the time of study entry are not excluded from participation. Pregnancy should be included in the Medical History section of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant during the study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–by-case basis.
Pregnancy in the Clinical Study. Women of childbearing potential or women who are pregnant at the time of study entry are not excluded from participation.
Pregnancy in the Clinical Study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case-by-case basis. Should a woman become pregnant during study participation, the pregnancy will be documented on the Medical History eCRF.
Pregnancy in the Clinical Study. If the subject becomes pregnant during the study, the investigator or sub-investigator will report it to Alcon Japan immediately. However, pregnancy is not included in adverse event. Subjects who become pregnant during the study will not be discontinued; however, all data will be excluded from the Best-Case Analysis Set (BAS).
Pregnancy in the Clinical Study. Pregnancy is excluded at the time of enrollment for this study. However, if a subject becomes pregnant during study participation, it will be documented on the source. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case-by-case basis.
Pregnancy in the Clinical Study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–by-case basis.
Pregnancy in the Clinical Study. Pregnancy should be included in the Medical History section of the eCRF if a woman becomes pregnant during the study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–by-case basis. An Alcon form will be utilized to capture all pregnancy-related information until birth of the child.
Pregnancy in the Clinical Study. Women who are pregnant at the time of study entry are excluded from participation. If any pregnancy is reported during the study, it should be included in the Medical History section of the eCRF. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–by-case basis. Continuous variables will be summarized using the number of observations, mean, standard deviation (SD), median, minimum and maximum, as well as confidence intervals (CIs) or confidence limits where applicable. Categorical variables will be summarized with counts and percentages from each category. Any deviations to the analysis plan will be updated during the course of the study as part of a protocol amendment or will be detailed in the clinical study report.
