Pregnancy information
End of study
Death of subject
text
Please fill out this item, if the date of death was in 2008-2015.
date
If the death: a) occurred while the subject was taking investigational product, b) was within the follow-up period, or c) was related to investigational product and was not caused by the disease under study, complete Serious Adverse Event form within 24 hours.
text
If the death: a) occurred while the subject was taking investigational product, b) was within the follow-up period, or c) was related to investigational product and was not caused by the disease under study, complete Serious Adverse Event form within 24 hours.
text
By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be invalidated in both instances. [hidden]
boolean
[hidden]
text
[hidden]
text
End of study details
Please fill out this item, if the date of dicontinuation was in 2008-2015.
date
Discontinuation before completion of all follow-up
text
Select "investigator descretion" only if the subject discontinues the study at the investigator's discretion and none of the other primary reasons apply. Select "withdrew consent" only if the subject withdraws consent and none of the other primary reasons apply.
integer
Select this reason only if the subject discontinues the study at the investigator's discretion and none of the other primary reasons apply.
text
Select this reason only if the subject withdraws consent and none of the other primary reasons apply.
text
Signature
CRB Electronic Signature Affidavit
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CRB Electronic Signature Affidavit, first name
text
CRB Electronic Signature Affidavit, last name
text
CRB Electronic Signature Affidavit, date
date
CRF Electronic Signature Affidavit
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CRF Electronic Signature Affidavit, first name
text
CRF Electronic Signature Affidavit, last name
text
CRF Electronic Signature Affidavit, date
date