Safe and effective self-injection was evaluated by the healthcare provider and is defined as:

• Dose Delivery: Subject self-injected the complete dose of Certolizumab Pegol (CZP) as confirmed by a visual inspection of the CZP-cassette(s) which shows the pre-filled syringe container to be empty AND
• No Adverse Events related to use of the e-Device (Adverse Device Effects) that would preclude continued use of the e-Device for self-injection.

For subjects on the Q4W (every 4 weeks) dosing regimen who would self-inject twice (2×200 mg CZP) at each visit, each injection was evaluated for safety and effectiveness using the above criteria. The primary endpoint of safe and effective self-injection for subjects on the Q4W dosing regimen was met only if both self-injections were determined to be safe and effective.

The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). Percentages were based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.

Safe and effective self-injection was evaluated by the healthcare provider and is defined as:

• Dose Delivery: Subject self-injected the complete dose of Certolizumab Pegol (CZP) as confirmed by a visual inspection of the CZP-cassette(s) which shows the pre-filled syringe container to be empty AND
• No Adverse Events related to use of the e-Device (Adverse Device Effects) that would preclude continued use of the e-Device for self-injection.

For subjects on the Q4W (every 4 weeks) dosing regimen who would self-inject twice (2×200 mg CZP) at each visit, each injection was evaluated for safety and effectiveness using the above criteria. The primary endpoint of safe and effective self-injection for subjects on the Q4W dosing regimen was met only if both self-injections were determined to be safe and effective.

The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). Percentages were based on the number of SS subjects that participated in Visit 1 and received at least 1 dose of CZP.

CZP-cassettes identified as having structural integrity issues meant CZP-cassettes with clear evidence of damage/compromised structural integrity, not superficial cosmetic imperfections.

The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). Percentages were based on the number of cassettes evaluated.

Blood pressure was measured in millimetre of mercury (mmHg).

The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.

Blood pressure was measured in millimetre of mercury (mmHg).

The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.

Pulse Rate was measured in beats per minute (beats/min).

The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.

Respiratory Rate was measured in breaths per minute (breaths/min).

The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.

Body Temperature was measured in Grad Celsius (°C).

The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.

An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product (IMP), whether or not related to the medicinal (investigational) product.

The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device).

An Adverse Device Event (ADE) was an AE related to the use of an investigational device. An ADE must have met 1 or more of the following criteria:

• Adverse event that resulted from insufficiencies or inadequacies in the Instructions for Use (IFU), the deployment, the implantation, the installation, the operation, or any malfunction of the investigational medical device
• Adverse event that was a result of an error or intentional misuse.

The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device).