Table 1

Pharmaceutical, trials, producers, dates and sources of CSRs in the review

Pharmaceutical and number (n) of assessed trial documentsTrial IDsManufacturerDate of CSRsProvenance in our study
Aripiprazole (Abilify) n=1CN1368135Bristol-Myers Squibb2007Freedom of Information request to the EMA
Arthronat n=1MA-CT-10–002Rowtasha2011Manufacturer website
Atorvastatin (Lipitor) n=1981–080Pfizer1999Freedom of Information request to the EMA
Clopidogrel (Plavix) n=5CURE, CLARITY, COMMIT-CCS2, CAPRIE, PICOLOBristol-Myers Squibb1997–2007Freedom of Information request to the EMA
Epoetin alfa (Epogen) n=1930 107Amgen1996Freedom of Information request to the FDA
H5N1 influenza vaccine n=1H5N1–008, H5N1–011 EXT 008GSK2006Freedom of Information request to the EMA
H5N1 influenza vaccines n=2V87P1, V87P6Novartis2008–2009Freedom of Information request to the EMA
Olanzapine (Zyprexa) n=3F1D-LC-HGAV*, F1D-MC-HGAO*, F1D-MC-HGAJ*Eli Lilly1995†Litigation
Oseltamivir (Tamiflu) n=19JV15823, JV15824, M76001, NP15757, NV16871, WP16263, WV15670, WV15671, WV15673, WV15697, WV15707, WV15708, WV15730, WV15758, WV15759, WV15871, WV15799, WV15812, WV15872, WV15819, WV15876, WV15978, WV15825, WV16193Roche1999–2004Documents obtained as part of previous Cochrane review12
Paroxetine (Paxil, Aropax, Pexeva, Seroxat, Sereupin) n=9329, 377, 453, 511, 676, 701, 704, 715, 716GSK1998–2002Litigation (2004 legal settlement mandated release of clinical study reports on manufacturer's website of 9 studies on paediatric and adolescent patients)
Quetiapine (Seroquel) n=7015, 041, 049, 125, 126, 127, 135AstraZeneca1996–2007Litigaton
Reboxetine (Edronax, Norebox, Prolift, Solvex, Davedax, Vestra) n=248, 9, 13, 14*, 15, 16, 17, 22*, 32, 32a, 34, 35, 37*, 43, 45, 46, 47, 49, 50, 52, 71, 83, 91, 96Pfizer1991–2009Health technology assessment website (The German IQWiG obtained CSRs as part of its health technology assessment work)
Rofecoxib (Vioxx) n=178Merck2003Litigation
Zanamivir (Relenza) n=9NAI30009, NAI300010, NAIA2005, NAIA3002, NAIA3005, NAIB2005, NAIB2007, NAIB3001, NAIB3002GSK1998–1999Documents obtained as part of previous Cochrane review12
  • *Subsequently excluded because of insufficient documentation.

  • †H1D-MC-HGAO clinical study report date unknown.

  • CSRs, clinical study reports; EMA, European Medicines Agency; FDA, Food and Drug Administration; GSK, GlaxoSmithKline; IQWiG, Institute for Quality and Efficiency in Healthcare; CAPRIE, Clopidogrel versus Aspirin In Patients at Risk of Ischaemic Events.