| Primary | Progression Free Survival | Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment. | All enrolled participants were considered for this outcome measure. | Posted | | Median | 95% Confidence Interval | months | | Approximately 5 years | | | | ID | Title | Description |
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| OG000 | Paclitaxel + Bevacizumab Arm | Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. |
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| Secondary | One Year Survival | The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported. | All enrolled participants were considered for this outcome measure. | Posted | | Number | | participants | | Approximately 5 years | | | | ID | Title | Description |
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| OG000 | Paclitaxel + Bevacizumab Arm | Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. |
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| Secondary | Time to Discontinuation (TTD) of Bevacizumab Treatment | Time to treatment discontinuation is defined as the time to change of therapy due to any cause (tumour progression, toxicity, or other causes) from the start of bevacizumab treatment. | All enrolled participants were considered for this outcome measure. | Posted | | Median | 95% Confidence Interval | months | | Approximately 5 years | | | | ID | Title | Description |
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| OG000 | Paclitaxel + Bevacizumab Arm | Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. |
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| Secondary | Participants With Hormone Receptor Status at Diagnosis | The hormone receptor status for Oestrogen (ER), Progesterone (PgR) and Human epidermal growth factor receptor (HER-2) is reported as positive, negative, unknown or missing. | All enrolled participants were considered for this outcome measure. | Posted | | Number | | participants | | Baseline (Day 1) | | | | ID | Title | Description |
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| OG000 | Paclitaxel + Bevacizumab Arm | Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. |
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| Secondary | Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry | PFS was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment for participants with triple negative status and not triple negative status. | All enrolled participants were considered for this outcome measure. Out of the total 220 enrolled participants, 106 participants were triple negative, 110 were not triple negative and data for 4 participants were missing. | Posted | | Median | 95% Confidence Interval | months | | Approximately 5 years | | | | ID | Title | Description |
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| OG000 | Paclitaxel + Bevacizumab Arm | Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. |
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| Secondary | Participants With Tumor Stage at Diagnosis | Number of participants at each Metastatic breast cancer stage 0, I, II, III or IV, at the point of diagnosis is reported. | All enrolled participants were considered for this outcome measure. | Posted | | Number | | participants | | Baseline (Day 1) | | | | ID | Title | Description |
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| OG000 | Paclitaxel + Bevacizumab Arm | Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. |
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| Secondary | Participants With Eastern Cooperative Oncology Group Status at Study Entry | The Eastern Cooperative Oncology Group (ECOG) status for participants was categorized as 0, 1, 2, or missing. ECOG has 4 grades as: 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care, totally confined to bed/chair. | All enrolled participants were considered for this outcome measure. | Posted | | Number | | participants | | Baseline (Day 1) | | | | ID | Title | Description |
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| OG000 | Paclitaxel + Bevacizumab Arm | Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. |
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| Secondary | Participants With Prior Therapy at Study Entry (Baseline) | The status of prior therapy (i.e. chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported. | All enrolled participants were considered for this outcome measure | Posted | | Number | | participants | | Baseline (Day 1) | | | | ID | Title | Description |
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| OG000 | Paclitaxel + Bevacizumab Arm | Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. |
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| Secondary | Participants With Disease History at Study Entry (Baseline) | Participant's history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline). | All enrolled participants were considered for this outcome measure. | Posted | | Number | | participants | | Baseline (Day 1) | | | | ID | Title | Description |
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| OG000 | Paclitaxel + Bevacizumab Arm | Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. |
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| Secondary | Participants With Type of Metastases at Study Entry (Baseline) | The type of metastases (bone and visceral) are reported at study entry (baseline) is reported. | All enrolled participants were considered for this outcome measure. | Posted | | Number | | participants | | Baseline (Day 1) | | | | ID | Title | Description |
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| OG000 | Paclitaxel + Bevacizumab Arm | Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. |
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| Secondary | Participants With Proteinuria at Study Entry (Baseline) | The number of participants with proteinurea status as positive, negative or missing is reported. | All enrolled participants were considered for this outcome measure | Posted | | Number | | participants | | Baseline (Day 1) | | | | ID | Title | Description |
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| OG000 | Paclitaxel + Bevacizumab Arm | Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. |
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