Trial Outcomes & Findings for Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly (NCT NCT02151149)

NCT ID: NCT02151149

Last Updated: 2018-09-24

Results Overview

Peripheral neuropathy (sensory or motor) assessment was done at screening, on Days 1, 8, 15 of every treatment cycle, at the End-of-Treatment visit and at the 28-day Follow-up Visit. Changes in neuropathy grade from baseline was reported as an AE as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Myelosuppression in participants receiving chemotherapy may have manifested as neutropenia, thrombocytopenia, or anemia. Grade 3 neutropenia including an absolute neutropenia count (ANC) of 500 to 1,000 cells/mm\^3; anemia hemoglobain levels (Hgb) \<8.0 - 6.5 g/dL; \<4.9 - 4.0 mmol/L; \<80 - 65 g/L; transfusion indicated; and thrombocytopenia with platelet levels \<100,000 cells/mm\^3.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 143 participants
• Primary outcome timeframe: From the date of the first dose of investigational product (IP) until 28 days after the last dose of IP; up to data cut-off date of 20 November 2016; The median treatment duration for Arms A and B were 3.04 months and 5.17 months respectively.
• Results posted on: 2018-09-24

Participant Flow

This multicenter study was conducted in the United States and enrolled participants at a total of 41 sites.

Participants ≥ 70 years old were randomized 1:1 to nab-paclitaxel and carboplatin on a 21-day treatment regimen or nab-paclitaxel and carboplatin on a 28-day treatment regimen; participants were stratified by Eastern Cooperative Oncology Group performance status (0 versus 1) and histology (squamous cell carcinoma versus non-squamous cell carcinoma)

Participant milestones

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Treatment Period STARTED	71	72
Treatment Period Treated Population	68	70
Treatment Period COMPLETED	1	1
Treatment Period NOT COMPLETED	70	71
Follow-Up Period STARTED	58	55
Follow-Up Period COMPLETED	19	18
Follow-Up Period NOT COMPLETED	39	37

Reasons for withdrawal

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Treatment Period Death	2	3
Treatment Period Adverse Event	17	14
Treatment Period Progressive Disease	25	24
Treatment Period Symptomatic Deterioration	2	10
Treatment Period Withdrawal by Subject	13	11
Treatment Period Miscellaneous	8	7
Treatment Period Participants randomized but not treated	3	2
Follow-Up Period Lost to Follow-up	2	3
Follow-Up Period Death	37	34

Baseline Characteristics

1 participant's disposition is missing

Baseline characteristics by cohort

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=71 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=72 Participants Participant ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8 and 15 followed by a one week break in each 28-day treatment cycle and carboplatin area under the curve (AUC) = 6 mg\*min/mL IV on Day 1 of each treatment cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Total n=143 Participants Total of all reporting groups
Age, Continuous	76.7 years STANDARD_DEVIATION 4.13 • n=71 Participants	76.4 years STANDARD_DEVIATION 5.18 • n=72 Participants	76.6 years STANDARD_DEVIATION 4.67 • n=143 Participants
Age, Customized 70-74 years	20 Participants n=71 Participants	33 Participants n=72 Participants	53 Participants n=143 Participants
Age, Customized 75-79 years	30 Participants n=71 Participants	18 Participants n=72 Participants	48 Participants n=143 Participants
Age, Customized 80-84 years	19 Participants n=71 Participants	17 Participants n=72 Participants	36 Participants n=143 Participants
Age, Customized 85-89 years	2 Participants n=71 Participants	2 Participants n=72 Participants	4 Participants n=143 Participants
Age, Customized ≥ 90 years	0 Participants n=71 Participants	2 Participants n=72 Participants	2 Participants n=143 Participants
Sex: Female, Male Female	30 Participants n=71 Participants	32 Participants n=72 Participants	62 Participants n=143 Participants
Sex: Female, Male Male	41 Participants n=71 Participants	40 Participants n=72 Participants	81 Participants n=143 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=71 Participants	1 Participants n=72 Participants	1 Participants n=143 Participants
Race/Ethnicity, Customized Asian	0 Participants n=71 Participants	3 Participants n=72 Participants	3 Participants n=143 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=71 Participants	7 Participants n=72 Participants	10 Participants n=143 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=71 Participants	1 Participants n=72 Participants	1 Participants n=143 Participants
Race/Ethnicity, Customized White	64 Participants n=71 Participants	57 Participants n=72 Participants	121 Participants n=143 Participants
Race/Ethnicity, Customized Other	1 Participants n=71 Participants	1 Participants n=72 Participants	2 Participants n=143 Participants
Race/Ethnicity, Customized Data Missing	3 Participants n=71 Participants	2 Participants n=72 Participants	5 Participants n=143 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 = Fully Active	21 Participants n=71 Participants	20 Participants n=72 Participants	41 Participants n=143 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 = Restricted in Physical Activity; Ambulatory	50 Participants n=71 Participants	52 Participants n=72 Participants	102 Participants n=143 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 2 = Ambulatory and Capable of All Self-care	0 Participants n=71 Participants	0 Participants n=72 Participants	0 Participants n=143 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 3 = Capable of Only Limited Self-care	0 Participants n=71 Participants	0 Participants n=72 Participants	0 Participants n=143 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 4 = Completely Disabled.	0 Participants n=71 Participants	0 Participants n=72 Participants	0 Participants n=143 Participants
Confirmed Histology Squamous Cell Carcinoma	27 Participants n=71 Participants	28 Participants n=72 Participants	55 Participants n=143 Participants
Confirmed Histology Non-Squamous Cell Carcinoma	44 Participants n=71 Participants	44 Participants n=72 Participants	88 Participants n=143 Participants
Stage of Disease at Enrollment IIIa	4 Participants n=71 Participants	5 Participants n=72 Participants	9 Participants n=143 Participants
Stage of Disease at Enrollment IIIb	6 Participants n=71 Participants	8 Participants n=72 Participants	14 Participants n=143 Participants
Stage of Disease at Enrollment IV	60 Participants n=71 Participants	59 Participants n=72 Participants	119 Participants n=143 Participants
Stage of Disease at Enrollment Data Missing	1 Participants n=71 Participants	0 Participants n=72 Participants	1 Participants n=143 Participants
Number of Prior Systemic Anticancer Therapies for Non-Small Cell Lung Cancer (NSCLC)	2.0 Therapies n=71 Participants	2.0 Therapies n=72 Participants	2.0 Therapies n=143 Participants
Body Mass Index (BMI)	26.357 Kg/m^2 STANDARD_DEVIATION 4.6805 • n=70 Participants • 1 participant's disposition is missing	26.033 Kg/m^2 STANDARD_DEVIATION 4.7562 • n=72 Participants • 1 participant's disposition is missing	26.193 Kg/m^2 STANDARD_DEVIATION 4.7051 • n=142 Participants • 1 participant's disposition is missing
Number of Participants with Peripheral Neuropathy at Baseline No Peripheral Neuropathy	54 Participants n=71 Participants	57 Participants n=72 Participants	111 Participants n=143 Participants
Number of Participants with Peripheral Neuropathy at Baseline Grade 1	14 Participants n=71 Participants	13 Participants n=72 Participants	27 Participants n=143 Participants
Number of Participants with Peripheral Neuropathy at Baseline Grade 2	1 Participants n=71 Participants	0 Participants n=72 Participants	1 Participants n=143 Participants
Number of Participants with Peripheral Neuropathy at Baseline Data Missing	2 Participants n=71 Participants	2 Participants n=72 Participants	4 Participants n=143 Participants

PRIMARY outcome

Timeframe: From the date of the first dose of investigational product (IP) until 28 days after the last dose of IP; up to data cut-off date of 20 November 2016; The median treatment duration for Arms A and B were 3.04 months and 5.17 months respectively.

Population: Treated Population included all participants who were randomized and received at least 1 dose of the study treatment.

Peripheral neuropathy (sensory or motor) assessment was done at screening, on Days 1, 8, 15 of every treatment cycle, at the End-of-Treatment visit and at the 28-day Follow-up Visit. Changes in neuropathy grade from baseline was reported as an AE as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Myelosuppression in participants receiving chemotherapy may have manifested as neutropenia, thrombocytopenia, or anemia. Grade 3 neutropenia including an absolute neutropenia count (ANC) of 500 to 1,000 cells/mm^3; anemia hemoglobain levels (Hgb) <8.0 - 6.5 g/dL; <4.9 - 4.0 mmol/L; <80 - 65 g/L; transfusion indicated; and thrombocytopenia with platelet levels <100,000 cells/mm^3.

Outcome measures

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=68 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=70 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Percentage of Participants With Either Peripheral Neuropathy ≥ Grade 2 or Myelosuppression Adverse Events (AEs) ≥ Grade 3 Based on Local Laboratory Values	76.5 Percentage of Participants Interval 64.6 to 85.9	77.1 Percentage of Participants Interval 65.6 to 86.3

SECONDARY outcome

Timeframe: From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively.

Population: Safety population included all participants who were randomized and received at least 1 dose of the study drug.

Treatment-emergent adverse events (TEAEs) were defined as any AE or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP. Any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the scale:

Grade 1 = Mild - transient or mild discomfort; Grade 2 = Moderate - mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required; Grade 3 = Severe - marked limitation in activity, assistance usually required; medical intervention required, hospitalization is possible; Grade 4 = Life threatening - extreme limitation in activity, assistance required; medical intervention, hospitalization or hospice care probable; Grade 5 = death.

Outcome measures

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=68 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=70 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period Grade 3 or Higher Treatment Emergent Adverse Event	60 Participants	61 Participants
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period Treatment Emergent Adverse Event	68 Participants	69 Participants
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period Serious Treatment Emergent Adverse Event	23 Participants	32 Participants
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period Grade 3 or 4 Treatment Emergent Adverse Event	60 Participants	59 Participants
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period Treatment Related TEAE	65 Participants	66 Participants
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period Treatment-Related Serious TEAE	12 Participants	12 Participants
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period TEAE with Action to Reduce or Interrupt IP Dose	60 Participants	54 Participants
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period Treatment-Related Action to Reduce/Interrupt IP	56 Participants	51 Participants
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period TEAE with Action Taken as Study Drug Withdrawn	17 Participants	14 Participants
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period Treatment-related TEAE with Action to Halt IP	13 Participants	13 Participants
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period TEAE with Fatal Outcome	1 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period Treatment-related TEAE with Fatal Outcome	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017 the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively

Population: Safety Population included all participants who were randomized and received at least 1 dose of study drug.

The percentage of participants with at least 1 TEAE with action taken as studydrug withdrawn during the treatment period of the trial was assessed throughout the conduct of the study. Study drug withdrawn (treatment permanently discontinued) was attributed to the part in which the onset of the adverse event took place.

Outcome measures

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=68 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=70 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event With Action Taken as Study Drug Withdrawn	25.0 Percentage of Participants	20.0 Percentage of Participants

SECONDARY outcome

Timeframe: From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively

Population: Treated Population included all randomized participants who received any study drug.

Dose intensity was the cumulative dose divided by the dosing period in weeks.

Outcome measures

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=68 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=70 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Dose Intensity Per Week of Nab-Paclitaxel During the Entire Study	64.07 mg/m^2/week Standard Deviation 17.374	56.57 mg/m^2/week Standard Deviation 16.645

SECONDARY outcome

Timeframe: From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively

Population: Treated Population included all randomized participants who received any study drug.

Dose intensity for carboplatin was the cumulative dose divided by the dosing period in weeks."

Outcome measures

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=68 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=70 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Dose Intensity Per Week of Carboplatin During the Entire Study	1.51 mg*min/mL/week Standard Deviation 0.384	1.33 mg*min/mL/week Standard Deviation 0.671

SECONDARY outcome

Timeframe: From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively

Population: The treated population consisted of all participants who received at least 1 dose of investigational product.

A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.

Outcome measures

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=68 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=70 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Percentage of Participants With Dose Reductions During the Entire Study nab-Paclitaxel	64.7 Percentage of Participants	58.6 Percentage of Participants
Percentage of Participants With Dose Reductions During the Entire Study Carboplatin	57.4 Percentage of Participants	58.6 Percentage of Participants

SECONDARY outcome

Timeframe: From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 16 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively

Population: The safety population consisted of all participants who received at least 1 dose of investigational product.

A dose delay occurred when the dose assigned at a visit was held compared to the previous visit. Dose delays were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.

Outcome measures

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=68 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=70 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Percentage of Participants With a Dose Delay During the Entire Study nab-Paclitaxel	58.8 Percentage of Participants	48.6 Percentage of Participants
Percentage of Participants With a Dose Delay During the Entire Study Carboplatin	52.9 Percentage of Participants	44.3 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose of IP to the date of disease progression; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for PFS for 31 months and 20 months respectively

Population: Intent to Treat Population all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed.

Progression-free survival was defined as the time in months from day 1 of treatment to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. RECIST V1.1 criteria includes: - Complete Response (CR) is the disappearance of all target lesions; - Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD); - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir

Outcome measures

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=71 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=72 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Kaplan Meier Estimate of Progression-Free Survival (PFS)	3.88 months Interval 3.02 to 6.24	7.20 months Interval 5.85 to 11.53

SECONDARY outcome

Timeframe: From first dose of IP to the date of death due to any cause; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for OS for 31 months and 33 months respectively

Population: Intent to Treat Population included all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed.

Overall survival was defined as the time in months between day 1 of treatment and death from any cause). Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.

Outcome measures

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=71 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=72 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Kaplan Meier Estimate of Overall Survival (OS)	14.52 months Interval 9.46 to 17.28	14.98 months Interval 12.09 to 18.73

SECONDARY outcome

Timeframe: From the first dose of IP to the date of documented first response; up to the data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively.

Population: Intent to Treat Population included all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed.

Overall response rate (ORR) was defined as the percentage of participants who had radiologic CR or PR compared to baseline (radiographic evaluation on the day of or within 28 days prior to randomization) according to RECIST Version 1.1 criteria as determined by the investigator, which was confirmed by repeated radiologic assessment performed no less than 28 days after the criteria for response were first met and occurred between Day 1 of treatment and the start of subsequent anticancer therapy, death or study discontinuation. A complete response and partial response per RECIST V 1.0 criteria was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of diameters of target lesions from baseline.

Outcome measures

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=71 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=72 Participants Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST 1.1 Criteria	26.8 Percentage of participants Interval 16.9 to 38.6	41.7 Percentage of participants Interval 30.2 to 53.9

Adverse Events

Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce)

Serious events: 23 serious events

Other events: 68 other events

Deaths: 45 deaths

Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle)

Serious events: 32 serious events

Other events: 69 other events

Deaths: 46 deaths

Serious adverse events

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=68 participants at risk Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=70 participants at risk Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Blood and lymphatic system disorders Anaemia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Blood and lymphatic system disorders Febrile neutropenia	2.9% 2/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Blood and lymphatic system disorders Leukopenia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Blood and lymphatic system disorders Neutropenia	8.8% 6/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	4.3% 3/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Blood and lymphatic system disorders Thrombocytopenia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Cardiac disorders Acute myocardial infarction	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Cardiac disorders Atrial fibrillation	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	4.3% 3/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Cardiac disorders Atrial flutter	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Cardiac disorders Atrial tachycardia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Cardiac disorders Atrial thrombosis	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Cardiac disorders Cardiac arrest	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Cardiac disorders Myocardial infarction	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Cardiac disorders Pericardial effusion	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Cardiac disorders Sinus tachycardia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Abdominal pain	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Constipation	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Diarrhoea	5.9% 4/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	2.9% 2/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Ileus	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Nausea	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Odynophagia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Pancreatitis	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Vomiting	2.9% 2/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	2.9% 2/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
General disorders Asthenia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
General disorders Chest pain	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
General disorders Generalised oedema	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
General disorders Pyrexia	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Hepatobiliary disorders Gallbladder obstruction	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Hepatobiliary disorders Hyperbilirubinaemia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Bronchitis	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Clostridium difficile colitis	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Diarrhoea infectious	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Diverticulitis	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Oesophageal candidiasis	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Pneumonia	2.9% 2/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	7.1% 5/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Sepsis	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Serratia infection	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Urinary tract infection	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	2.9% 2/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Injury, poisoning and procedural complications Fall	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Injury, poisoning and procedural complications Femoral neck fracture	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Injury, poisoning and procedural complications Femur fracture	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Investigations Alanine aminotransferase increased	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Investigations Aspartate aminotransferase increased	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Investigations Blood alkaline phosphatase increased	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Cachexia	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Dehydration	2.9% 2/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	2.9% 2/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Hypoglycaemia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Hypokalaemia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Hyponatraemia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Musculoskeletal and connective tissue disorders Muscular weakness	2.9% 2/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Musculoskeletal and connective tissue disorders Pain in extremity	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Nervous system disorders Dizziness	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Nervous system disorders Encephalopathy	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Nervous system disorders Seizure	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Nervous system disorders Syncope	2.9% 2/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	2.9% 2/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Psychiatric disorders Delirium	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	2.9% 2/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Psychiatric disorders Mental status changes	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	2.9% 2/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Renal and urinary disorders Acute kidney injury	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Renal and urinary disorders Renal failure	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	2.9% 2/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.4% 3/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	8.6% 6/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	2.9% 2/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.9% 2/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	2.9% 2/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Vascular disorders Deep vein thrombosis	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Vascular disorders Hypotension	0.00% 0/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Vascular disorders Orthostatic hypotension	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.

Other adverse events

Measure	Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) n=68 participants at risk Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) n=70 participants at risk Participants ≥ 70 years old received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg\*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Blood and lymphatic system disorders Anaemia	66.2% 45/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	55.7% 39/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Blood and lymphatic system disorders Leukopenia	20.6% 14/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	15.7% 11/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Blood and lymphatic system disorders Neutropenia	51.5% 35/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	45.7% 32/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Blood and lymphatic system disorders Thrombocytopenia	44.1% 30/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	27.1% 19/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Eye disorders Vision blurred	4.4% 3/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	5.7% 4/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Abdominal pain	13.2% 9/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	12.9% 9/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Constipation	36.8% 25/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	28.6% 20/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Diarrhoea	42.6% 29/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	37.1% 26/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Dysphagia	5.9% 4/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	7.1% 5/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.4% 5/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	8.6% 6/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Nausea	47.1% 32/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	52.9% 37/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Stomatitis	20.6% 14/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	11.4% 8/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Gastrointestinal disorders Vomiting	19.1% 13/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	28.6% 20/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
General disorders Asthenia	10.3% 7/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	4.3% 3/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
General disorders Chills	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	8.6% 6/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
General disorders Fatigue	67.6% 46/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	52.9% 37/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
General disorders Non-cardiac chest pain	4.4% 3/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	7.1% 5/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
General disorders Oedema peripheral	17.6% 12/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	18.6% 13/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
General disorders Pain	8.8% 6/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
General disorders Pyrexia	7.4% 5/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	10.0% 7/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Oral candidiasis	5.9% 4/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Pneumonia	5.9% 4/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	7.1% 5/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Upper respiratory tract infection	8.8% 6/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	4.3% 3/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Infections and infestations Urinary tract infection	10.3% 7/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	8.6% 6/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Injury, poisoning and procedural complications Contusion	5.9% 4/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Injury, poisoning and procedural complications Fall	7.4% 5/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	10.0% 7/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Injury, poisoning and procedural complications Overdose	8.8% 6/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Investigations Blood creatinine increased	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	5.7% 4/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Investigations Neutrophil count decreased	20.6% 14/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	18.6% 13/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Investigations Platelet count decreased	13.2% 9/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	8.6% 6/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Investigations Weight decreased	13.2% 9/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	18.6% 13/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Investigations White blood cell count decreased	7.4% 5/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	10.0% 7/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Decreased appetite	32.4% 22/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	37.1% 26/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Dehydration	23.5% 16/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	24.3% 17/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Hyperglycaemia	10.3% 7/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	7.1% 5/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Hypocalcaemia	5.9% 4/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	7.1% 5/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Hypokalaemia	14.7% 10/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	24.3% 17/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Hypomagnesaemia	11.8% 8/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	20.0% 14/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Metabolism and nutrition disorders Hyponatraemia	16.2% 11/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 5/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	14.3% 10/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Musculoskeletal and connective tissue disorders Back pain	11.8% 8/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	10.0% 7/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Musculoskeletal and connective tissue disorders Muscular weakness	7.4% 5/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	18.6% 13/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.4% 5/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	4.3% 3/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Musculoskeletal and connective tissue disorders Pain in extremity	10.3% 7/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	11.4% 8/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Nervous system disorders Dizziness	20.6% 14/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	20.0% 14/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Nervous system disorders Dysgeusia	10.3% 7/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	14.3% 10/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Nervous system disorders Headache	10.3% 7/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	10.0% 7/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Nervous system disorders Peripheral motor neuropathy	10.3% 7/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	15.7% 11/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Nervous system disorders Peripheral sensory neuropathy	58.8% 40/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	42.9% 30/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Psychiatric disorders Anxiety	2.9% 2/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	14.3% 10/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Psychiatric disorders Insomnia	11.8% 8/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	5.7% 4/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Cough	23.5% 16/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	17.1% 12/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Dysphonia	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	5.7% 4/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.5% 16/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	24.3% 17/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Epistaxis	23.5% 16/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	14.3% 10/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Haemoptysis	7.4% 5/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	0.00% 0/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.9% 4/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	1.4% 1/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Skin and subcutaneous tissue disorders Alopecia	39.7% 27/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	41.4% 29/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Skin and subcutaneous tissue disorders Dry skin	8.8% 6/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	5.7% 4/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.8% 8/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	11.4% 8/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Vascular disorders Hypertension	1.5% 1/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	5.7% 4/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
Vascular disorders Hypotension	5.9% 4/68 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.	18.6% 13/70 • TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.

Additional Information

Anne McClain, Senior Manager

Celgene Corporation

Phone: 888-260-1599

Email: ClinicalTrialDisclosure@Celgene.com

Results disclosure agreements

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