A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.

Time frame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Population: Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study)

The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom severity score is defined as average over 13 core symptom items and 9 brain tumor symptom items, with a total score of 0 to 10, with higher score indicating worse symptoms/interference. Changes in symptom severity score were classified into 3 categories: improved (≤ -1), stable (\> -1 and \< 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom severity score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.

Time frame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Population: Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study)

The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom interference score is defined as an average of 6 interference items, with a total score of 0 to 10, where higher scores indicate worse interference. Changes in symptom interference score were classified into 3 categories: improved (≤ -1), stable (\> -1 and \< 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom interference score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.

Time frame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Population: Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study)

The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. When scoring the HVLT-R, the 3 learning trials are combined to calculate a total recall score (range -12 to 60). Deterioration is defined as satisfying the deterioration criteria (i.e., decrease in HVLT-R total recall score by 5 units) without further improvement within 8 weeks or occurrence of death.

Time frame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Population: Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study)

Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.

Time frame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Population: Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) Participants with EGFR-VIII mutation status=mutated.

Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.

Time frame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Population: Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) Participants with methylated MGMT promoter status.

Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause. Unmethylated MGMT promoter is associated with a worse prognosis in GBM

Time frame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Population: Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) Participants with unmethylated MGMT promoter status.

PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur.

Time frame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Population: Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) Participants with EGFR-VIII mutation status=mutated.

PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria (see Wen et al. J Clin Oncol. 2010 Apr 10;28(11):1963-72) or to the date of death, if disease progression does not occur.

Time frame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Population: Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study)