Table 1.
Design and Key Features of NordiNet IOS and ANSWER
| NordiNet IOS | ANSWER | |
|---|---|---|
| Study start | 1 April 2006 | 24 June 2002 |
| Study end | 31 December 2016 | 30 September 2016 |
| No. of countries involved (no. of patients per country) | 22 [Belgium (11), Czech Republic (1213), Denmark (719), Finland (211), France (3619), Germany (7008), Hungary (86), Ireland (41), Israel (152), Italy (103), Lithuania (103), Luxembourg (2), Montenegro (85), Netherlands (152), Norway (297), Russia (156), Serbia (1299), Slovenia (281), Spain (6), Sweden (941), Switzerland (523), United Kingdom (694)]a | 1 [United States (19,847)] |
| No. of clinics | 469 | 207 |
| Important protocol amendments | Prior to protocol amendment 3 (30 September 2013), only nonserious ARs and SAEs, regardless of relatedness, MESIs, and pregnancies, were collected. The change to the protocol was due to new pharmacovigilance legislation, which came into effect in July 2012. ARs and SARs considered related to GH, and SAEs considered unrelated to GH, were included in this report | Prior to protocol amendment 2 (9 November 2011), very few events were reported to the study. This is likely to have reflected the way ARs and SARs were described in earlier versions of the protocol and revised text, with amendment 2 more clearly explaining the collection and reporting of safety information. Only events reported after this date were included in this report |
Abbreviations: AR, adverse reaction; MESI, medical event of special interest; SAE, serious adverse event; SAR, serious adverse reaction.
a
One additional country, Saudi Arabia, participated in the study and registered patients to the International Outcomes database; however, none of those satisfied the inclusion criteria of the study.