Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer

Overall Response Rate (ORR)

Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), as per Blinded Independent Review Committee (BIRC) assessment and according to RECIST 1.1.

Time frame: From randomization up to approximately 2 years

Overall Survival (OS)

Overall Survival (OS) is defined as the time from the date of randomization to the date of death due to any cause.

Time frame: From randomization to death assessed up to approximately 5 years

Duration of Response (DOR)

Duration of Response (DOR) applied only to patients whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR), as determined by the Blinded Independent Review Committee (BIRC) assessment according to RECIST 1.1. The start date was defined as the date of the first documented confirmed CR or PR, and the end date corresponded to the date of the first documented confirmed progression or death from any cause. Patients who remained without progression or death from any cause were censored at the date of their last adequate tumor assessment prior to the initiation of any new antineoplastic therapy.

Time frame: From the start date of the first documented response of complete response or partial response and the date defined as the date of the first documented progression or death due to any cause up to 2 years

Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

The distribution of adverse events will be conducted through the analysis of frequencies for treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs), based on the monitoring of relevant clinical and laboratory safety parameters. Treatment-emergent adverse events (TEAEs) in this study will be defined as events that begin after the first dose of study treatment and continue until 30 days after the last dose, or events that are present prior to the first dose and increase in severity based on preferred term within 30 days following the last dose.

Time frame: Throughout study completion, an average 5 years

Number of participants with trametinib associated serous retinopathy ocular events

Standard ophthalmic examinations were performed by an ophthalmologist, and Optical Coherence Tomography (OCT) was conducted at mandated visits. Analysis of the optical coherence tomography data was carried out to evaluate the incidence, type, and severity of trametinib-associated serous retinopathy ocular events.

Time frame: screening, week 4, week 8, week 12, week 20 and every 12 weeks after week 20, up to approximately 2 years