During the clinical development programme, increases in mean serum creatinine (SCr) of approximately 0.07 mg/dL and 0.08 mg/dL were observed which plateaued early.
The good efficacy of tocilizumab was accompanied by a manageable safety profile, which was in accordance with the safety data obtained during the clinical development programme of tocilizumab.
One patient in the psoriasis clinical development programme developed cutaneous lupus erythematosus, which was not considered an SAE by the investigator.
6 The current analysis was part of a premarketing risk assessment that focused on malignancies occurring in patients in the abatacept clinical development programme (CDP).
Thus, all analyses of nocturnal hypoglycaemia in the clinical development programme for insulin degludec were carried out according to the definition set a priori for nocturnal hypoglycaemia— hypoglycaemic episodes occurring between 00 01 and 05:59 h (both inclusive).
The aim of this pre-planned meta-analysis was to show the superiority of IDeg over IGlar in terms of hypoglycaemic episodes at equivalent HbA1c using pooled, individual patient-level data from all phase 3 trials in the IDeg clinical development programme, as discussed in advance with the regulatory authorities.
The data were fully anonymised and were available as a component of an ongoing clinical development programme.
Pooled patient-level data for self-reported hypoglycaemia from all seven fivee in T2DM and two in T1DM) randomized, controlled, phase 3a, treat-to-target trials in the IDeg clinical development programme comparing IDeg once-daily (OD) vs. IGlar OD were analysed.
The analysis presented here includes previously unreported data from insulin-naïve patients with type 2 diabetes who were studied for a total of 2 years in a 52-week trial with a 52-week extension; this was the largest of the phase 3 trials in the IDeg clinical development programme 9.
Cases of RPLS had been observed in other studies in the ziv-aflibercept clinical development programme but the rate observed in this study was higher than previously observed.
Rare cases of RPLS have been observed in the ziv-aflibercept clinical development programme but the rate observed in this study (3 out of 42=7%) was much higher than previously reported (i.e., 0.5% of 3795 patients treated with ziv-aflibercept as monotherapy or in combination with chemotherapy, ZALTRAP product insert).
