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

The full analysis set (FAS), which was defined as all randomized participants

TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD.

The full analysis set (FAS), which was defined as all randomized participants

Disease control was defined as the number of participants who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD.

The full analysis set (FAS), which was defined as all randomized participants

The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems'). The 5 health dimensions are summarized into a single score, the EQ-5D index score. The EQ-5D index score has a range of 0 and 1 with 0 representing death and 1 representing perfect health.

The full analysis set (FAS), which was defined as all randomized participants

Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.

The full analysis set (FAS), which was defined as all randomized participants

Duration of response - RECIST: number of days from the date that CR or PR is first documented to date that PD is first objectively documented or to death before progression. Note: the relevant date is that of the first documentation, not the confirmation date (if participant progressed or died then censored=no) or to last observation if participant did not progress or die then censored=yes note: this last observation date should be the same as that used for time to progression.

The full analysis set (FAS), which was defined as all randomized participants. Duration of response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR.

Time to response was the number of days from randomization to the date the CR or PR was documented (with confirmation) (Note: the relevant date is that of the first documentation, not the confirmation date).

The full analysis set (FAS), which was defined as all randomized participants. Time to response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR.

Tumor response was the proportion of participants with the best tumor response (ie, achieving either a confirmed complete response [CR] or partial response [PR], according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria).

The full analysis set (FAS), which was defined as all randomized participants