In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain was seen by week 1 and was maintained throughout the treatment period.

Methylnaltrexone bromide treatment has not been studied in clinical trials for longer than 4 months, and should therefore only be used for a limited period (see section 5.2).

The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1). i dic

This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials of 48 weeks duration in treatment-experienced patients (see section 5.1).

In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical trials) in children and adolescents (ages 6 to 17) was similar to that seen for adults.

In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45 % of patients treated with ARICLAIM and 23 % of patients taking placebo.

In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45 % of patients treated with CYMBALTA and 23 % of patients taking placebo.

The adverse event profile for topotecan when given in combination with cisplatin in the cervical cancer clinical trials is consistent with that seen with topotecan monotherapy.

In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45 % of patients treated with XERISTAR and 23 % of patients taking placebo.

These comparative tests and trials shall be used to harmonise the technical methods of certification and to check satisfaction of the conditions with which the seed must comply.

In a clinical trial adverse events seen on abrupt treatment discontinuation occurred in approximately 44 % of patients treated with ARICLAIM and 24 % of patients taking placebo.

In a clinical trial adverse events seen on abrupt treatment discontinuation occurred in approximately 44 % of patients treated with YENTREVE and 24 % of patients taking placebo.

Malignancies The overall observed incidence rate of malignancy in the Xolair clinical trial programme was comparable to that reported in the general population (see section 4.4).

In Trial 4, the response was numerically similar for patients treated with doses of 6 to 9 g/ day, but there was no effect seen in patients treated with doses less than 6 g/ day.

In addition, in these trials efficacy has not been adequately demonstrated (see section 4.4 Special Warnings and Special Precautions for use and section 4.8 Undesirable Effects).

Similar changes were seen in metformin (haemoglobin 3 - 4 % and haematocrit 3.6 – 4.1 % relative reductions) treated patients in comparative controlled trials with pioglitazone.

The results of the HOPE and PEACE trials seem to support the beneficial effect of perindopril observed in the EUROPA study for patients with medium to high risk of cardiac events.

As a consequence of these benign effects, more FABLYN-treated patients had a diagnostic uterine procedure compared to placebo-treated patients in the PEARL trial (see section 5.1).

Community comparative trials and tests should be carried out in the years 2004 and 2005 on seeds and propagating material harvested in 2003, and the details of such trials and tests, the eligible costs as well as the maximum Community financial contribution should also be set out yearly by an agreement signed by the authorising officer of the Commission and the body responsible for the carrying-out of trials.

The clinical trials conducted in indications other than liver and kidney transplantation have been quite small and seem to have been investigator driven rather then driven by the MAH.

Malignancies In the placebo-controlled clinical trials, the frequencies of malignancies in abatacept- and placebo-treated patients were 1.4 % and 1.1 %, respectively (see section 4.8).

• Undesirable effects Expansion of withdrawal symptoms seen on discontinuation of paroxetine treatment and inclusion of information on adverse events from paediatric clinical trials.

In a clinical pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the clinical dose) for ten days, no prolongation of QTc interval was seen.

There is limited clinical trial experience with the use of Tracleer in patients with PAH associated with HIV infection, treated with antiretroviral medicinal products (see section 5.1).

Efficacy information in tibia fracture is available only from controlled clinical trials in which open tibial fractures were treated using intramedullary nail fixation (see section 5.1).

In the 30-week placebo-controlled clinical trials, concomitant use of BYETTA and HMG CoA reductase inhibitors was not associated with consistent changes in lipid profiles (see section 5.1).

Although ziconotide has been studied in long-term, open label efficacy and safety clinical trials, controlled studies of longer than 3 weeks duration have not been conducted (see section 5.1).

There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following MabThera (see section 4.5).

in the case of the upper part of outboard seats, a zone with a triangular cross-section whose apex is situated 650 mm from the floor and whose base is 100 mm in width (see Annex III, figure 15);

The majority of the adverse reactions were transient The adverse reaction profile in clinical trials with patients with benign prostatic hyperplasia corresponded to the one seen in hypertension.

In the remaining nine trials (Europe, Canada, USA, Latin America, Singapore, South-Africa), Rotarix lyophilised formulation was co-administered with routine paediatric vaccines (see section 4.5).

A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see 5.1).

Continued durable responses have been seen for up to 48 months in open-label extension treatment trials when patients received Enbrel without interruption; longer-term experience is not available.

In the 48 week analysis of the ARTEMIS trial (see Clinical experience subsection ART-naïve patients), 9.9% virologic failures were observed in patients receiving PREZISTA/ritonavir 800/100 mg q.d.

Wound healing (see section 4.4): As Avastin may adversely impact wound healing, patients who had major surgery within the last 28 days were excluded from participation in phase III clinical trials.

Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia. Hospitalisation or fatal outcomes associated with infections have been reported.

In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45 % of patients treated with DULOXETINE BOEHRINGER INGELHEIM and 23 % of patients taking placebo.

There have been no therapeutic clinical trials conducted with Efficib tablets however bioequivalence of Efficib with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).

There have been no therapeutic clinical trials conducted with Janumet tablets however bioequivalence of Janumet with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).

In a clinical trial adverse events seen on abrupt treatment discontinuation occurred in approximately 44 % of patients treated with DULOXETINE BOEHRINGER INGELHEIM and 24 % of patients taking placebo.

In a controlled clinical trial in type 2 diabetic patients with proteinuria (RENAAL study, see section 5.1) the most common drug-related adverse events which were reported for losartan are as follows:

Adverse reactions from clinical trials with different formulations (H5N1, H2N2 and H9N2) (N=941) of the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up vaccines).

There have been no therapeutic clinical trials conducted with Velmetia tablets however bioequivalence of Velmetia with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).

In clinical trials in which pioglitazone was compared to other oral anti diabetic drugs or placebo (dummy pill), a higher number of bone fractures was seen in women (but not in men) taking pioglitazone.

There have been no therapeutic clinical trials conducted with Glubrava tablets however bioequivalence of Glubrava with co-administered pioglitazone and metformin has been demonstrated (see section 5.2).

In clinical trials, adverse events seen on treatment discontinuation (tapering and post-tapering) occurred in approximately 35 % of patients treated with venlafaxine and 17 % of patients taking placebo.

Treatment of women: In approximately 4 % of the women treated with Puregon in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4).

A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1).

There have been no therapeutic clinical trials conducted with Competact tablets however bioequivalence of Competact with co-administered pioglitazone and metformin has been demonstrated (see section 5.2).

The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of Enbrel in adult patients with rheumatoid arthritis, and the majority were mild.