0.5

Few patients experienced serious adverse events

Adverse event reporting forms

Both individuals recovered from these adverse events.

The applicant has submitted the total number of adverse events with no distinction between adverse events related or not related.

Causality has not been determined for all adverse events.

Dose related adverse events cannot be excluded.

Of the 908 participants, 239 thereof experienced adverse events (AEs).

No adverse events have been reported in the target species.

The frequency of adverse reactions is defined using the following convention

15 of SAEs involved liver toxicity.

15 of SAEs involved liver toxicity.

The frequency and severity of adverse events were also lower.

For section 4.8, the CHMP assessed and completely revised the text of the SPC, taking into account new adverse event and tightening the section by revising the grouping of terms of adverse events.

No serious adverse events have been reported in the study volunteers.

Adverse events in paediatric patients Adverse events information are derived from the clinical study in paediatrics (n 55).

Adverse events information are derived from the clinical study in paediatrics (n 55).

Adverse reactions information are derived from the clinical study in paediatrics (n 55).

If not sufficient to manage the adverse events, the opicapone dose could then be down titrated.

8 Adverse events reported in the ESPRIT trial are listed in Table 3.

22 Adverse events reported in the ESPRIT trial are listed in Table 3.

Subacute toxicity studies did not reveal any unexpected adverse events.

Additional adverse events were seen when topotecan was given in combination with cisplatin, however, these events were seen with cisplatin monotherapy and not attributable to topotecan.

Averse events in adults Adverse events information is derived from two clinical trials (n 103) of Busilvex.

Additional adverse events were seen when topotecan was given in combination with cisplatin, however, these events were seen with cisplatin monotherapy and not attributable to topotecan.

However, subsequent studies showed that it increased adverse events bleeding risk in particular and did not decrease mortality.

For other adverse events, the levodopa and or opicapone dose could be adjusted.

Increases in lamotrigine concentrations may be associated with dose related adverse events.

No serious adverse events related to NEVANAC were reported in these studies.

It is unlikely that these differences will result in clinically relevant adverse events.

Most reported adverse events were not unexpected, mainly gastro intestinal disorders or cutaneous disorders.

Systemic adverse events including non ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors.

Most of the adverse events were of mild or moderate severity in both groups.

No adverse effects were observed at the maximum exposure dose of 4 mg kg.

The most common adverse events reported were local reactions at the injection site.

Skin lp

the lack of an overall survival benefit versus adverse events in locally advanced prostate cancer

The incidence and nature of most adverse events were similar in the two treatment groups.

The response to therapy should be assessed periodically, and the occurrence of adverse events closely monitored.

During the randomised period of the EUROPA study, only serious adverse events were collected.

No case of neurological AE was reported after introduction of STAMARIL.

Safety profile Overall Comparison of Adverse Events in Phase I III Studies A total of five clinical trials (BTC 9901, MRZ 0113, BTC 9801, MRZ 0013, MRZ 0003) have been completed to provide data on the safety and efficacy of Xeomin.

Adverse events information is derived from two clinical trials (n 103) of Busilvex.

Adverse reactions information is derived from two clinical trials (n 103) of busulfan.

The incidence and nature of most adverse events were similar in the two treatment groups.