Addition of two new examples (fourth and fifth examples in the table) Note also that this section number has changed from 3.17 to 3.18. 3.18.1 Overdose reported with clinical consequences In the Example table, the order of the LLTs in the Selected” column has “LLT been changed so that the first LLT (LLT Overdose) reflects the topic of this section. (See document”, point no. 6 above). “Throughout Note also that this section number has changed from 3.17.1 to 3.18.1. 3.19.2 Device-related event reported without clinical consequences An additional (third) example was added to the Example table: Example Reported LLT Selected Medical device breakage Device breakage My patch is leaking on my arm Leaking patch As follows: Example Reported LLT Selected Medical device breakage Device breakage My is leaking on my arm Leaking patch My patch is not sticking to my skin Medicinal patch adhesion issue Note also that this section number has changed from 3.18.2 to 3.19.2. 3.22 Unexpected Therapeutic Effect –
Addition of two new examples (fourth and fifth examples in the table) Note also that this section number has changed from 3.17 to 3.18. 3.18.1 Overdose reported with clinical consequences In the Example table, the order of the LLTs in the “LLT Selected” column has been changed so that the first LLT (LLT Overdose) reflects the topic of this section. (See “Throughout document”, point no. 6 above). Note also that this section number has changed from 3.17.1 to 3.18.1. 3.19.2 Device-related event reported without clinical consequences An additional (third) example was added to the Example table: Example Reported LLT Selected Medical device breakage Device breakage My patch is leaking on my arm Leaking patch As follows: Example Reported LLT Selected Medical device breakage Device breakage My is leaking on my arm Leaking patch My patch is not sticking to my skin Medicinal patch adhesion issue Note also that this section number has changed from 3.18.2 to 3.19.2. 3.22 – Unexpected Therapeutic Effect
termselptc_r4.5soc_mar2013.docx