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Table 1 Sources and data cut-offs used in primary and additional ITCs

From: Indirect treatment comparison of dabrafenib plus trametinib versus vemurafenib plus cobimetinib in previously untreated metastatic melanoma patients

Outcome COMBI-v coBRIM
Data cut-off Data source Data cut-off Data source
Efficacy outcomes
OS Primary Analysis —March 2015
Additional analysis (without crossover)—April 2014
Additional analysis (LDH subgroups)—March 2015
Robert 2015b [29]
Robert 2015a [27]
Novartis Pharmaceuticals Corporation, unpublished observations
August 2015 Atkinson 2015 [30]
PFS Primary analysis—March 2015 Robert 2015b [29] January 2015 Larkin 2015c [32]
Additional analysis
LDH subgroups—April 2014
Novartis Pharmaceuticals Corporation, unpublished observations
ORR April 2014 Robert 2015a [27] January 2015 Larkin 2015c [32]
General adverse events
Any AE, any SAE, discontinuation due to AE, AE leading to death, any grade ≥3 AE March 2015 Robert 2015b [29]
and Novartis Pharmaceuticals Corporation, unpublished observations
September 2014 EMA label [33, 34]
Any treatment-related AE, any dose interruptions/modifications April 2014 Robert 2015a [27]
Specific adverse events
All specific adverse events except those highlighted in the row below March 2015 Robert 2015b [29]
and Novartis Pharmaceuticals Corporation, unpublished observations
September 2014 EMA label
Keratocanthoma May 2014 Larkin 2014 [21]
CuSCC—all grades April 2014
Chills—all grades grade 3 to 5: alopecia, nausea, pyrexia, vomiting March 2015 May 2014 EMA label
  1. AE Adverse event, CuSS cutaneous squamous cell carcinoma, D + T dabrafenib plus trametinib, ECOG Eastern Cooperative Oncology Group, EMA European Medicines Agency, ITC Indirect treatment comparison, LDH lactate dehydrogenase, OS Overall survival, ORR Overall response rate, PFS Progression-free survival, SAE Severe adverse event, V vemurafenib, V + C vemurafenib plus cobimetinib