Trial Outcomes & Findings for A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine (NCT NCT02915744)

NCT ID: NCT02915744

Last Updated: 2023-04-14

Results Overview

To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 178 participants
• Primary outcome timeframe: Within 3 years from study start
• Results posted on: 2023-04-14

Participant Flow

Participant milestones

Measure	NKTR-102 NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Overall Study STARTED	92	86
Overall Study COMPLETED	13	9
Overall Study NOT COMPLETED	79	77

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine

Baseline characteristics by cohort

Measure	NKTR-102 n=92 Participants NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=86 Participants TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.	Total n=178 Participants Total of all reporting groups
Age, Continuous	54.7 years STANDARD_DEVIATION 10.13 • n=5 Participants	51.9 years STANDARD_DEVIATION 10.50 • n=7 Participants	53.3 years STANDARD_DEVIATION 10.37 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	86 Participants n=7 Participants	178 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	69 Participants n=5 Participants	60 Participants n=7 Participants	129 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants	57 Participants n=7 Participants	123 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) 0	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) 1	67 Participants n=5 Participants	61 Participants n=7 Participants	128 Participants n=5 Participants
Reproductive Status Of Child-Bearing Potential	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Reproductive Status Surgically Sterile	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Reproductive Status Post-Menopausal	65 Participants n=5 Participants	55 Participants n=7 Participants	120 Participants n=5 Participants
Reproductive Status Other	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Reproductive Status Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Pregnancy Test at Screening Performed	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Pregnancy Test at Screening Positive	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Pregnancy Test at Screening Negative	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Pregnancy Test at Screening Borderline	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Pregnancy Test at Screening Not Performed	63 Participants n=5 Participants	60 Participants n=7 Participants	123 Participants n=5 Participants
Height	162.7 centimeters STANDARD_DEVIATION 6.67 • n=5 Participants	162.1 centimeters STANDARD_DEVIATION 7.73 • n=7 Participants	162.4 centimeters STANDARD_DEVIATION 7.19 • n=5 Participants
Weight	67.16 kilograms STANDARD_DEVIATION 17.468 • n=5 Participants	65.97 kilograms STANDARD_DEVIATION 15.561 • n=7 Participants	66.59 kilograms STANDARD_DEVIATION 16.539 • n=5 Participants
Time since Initial Breast Cancer Diagnosis	8.094 years STANDARD_DEVIATION 5.1700 • n=5 Participants	6.950 years STANDARD_DEVIATION 5.0941 • n=7 Participants	7.541 years STANDARD_DEVIATION 5.151 • n=5 Participants
Breast Cancer at Initial Diagnosis I	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Breast Cancer at Initial Diagnosis II	41 Participants n=5 Participants	29 Participants n=7 Participants	70 Participants n=5 Participants
Breast Cancer at Initial Diagnosis III	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Breast Cancer at Initial Diagnosis IV	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Breast Cancer at Initial Diagnosis Unknown	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Cancer Histology at Initial Diagnosis Invasive Ductal Carcinoma	80 Participants n=5 Participants	77 Participants n=7 Participants	157 Participants n=5 Participants
Cancer Histology at Initial Diagnosis Invasive Lobular Carcinoma	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Cancer Histology at Initial Diagnosis Other	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Estrogen Receptor Status at Initial Diagnosis ER Positive	52 Participants n=5 Participants	49 Participants n=7 Participants	101 Participants n=5 Participants
Estrogen Receptor Status at Initial Diagnosis ER Negative	40 Participants n=5 Participants	34 Participants n=7 Participants	74 Participants n=5 Participants
Estrogen Receptor Status at Initial Diagnosis Unknown	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Progesterone Receptor (PgR) Status at Initial Diagnosis PgR Positive	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants
Progesterone Receptor (PgR) Status at Initial Diagnosis PgR Negative	50 Participants n=5 Participants	41 Participants n=7 Participants	91 Participants n=5 Participants
Progesterone Receptor (PgR) Status at Initial Diagnosis Unknown	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Human Epidermal Growth Factor Receptor (HER2) Status at Initial Diagnosis HER2 Positive	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Human Epidermal Growth Factor Receptor (HER2) Status at Initial Diagnosis HER2 Negative	76 Participants n=5 Participants	66 Participants n=7 Participants	142 Participants n=5 Participants
Human Epidermal Growth Factor Receptor (HER2) Status at Initial Diagnosis Unknown	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Estrogen Receptor Status at Last Biopsy ER Positive	47 Participants n=5 Participants	48 Participants n=7 Participants	95 Participants n=5 Participants
Estrogen Receptor Status at Last Biopsy ER Negative	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Estrogen Receptor Status at Last Biopsy Unknown	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Progesterone Receptor Status at Last Biopsy PgR Positive	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Progesterone Receptor Status at Last Biopsy PgR Negative	51 Participants n=5 Participants	52 Participants n=7 Participants	103 Participants n=5 Participants
Progesterone Receptor Status at Last Biopsy Unknown	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
HER2 Receptor Status at Last Biopsy HER2 Positive	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
HER2 Receptor Status at Last Biopsy HER2 Negative	74 Participants n=5 Participants	69 Participants n=7 Participants	143 Participants n=5 Participants
HER2 Receptor Status at Last Biopsy Unknown	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Estrogen Receptor/Progesterone Receptor Status at Last Biopsy ER/PgR Positive	49 Participants n=5 Participants	49 Participants n=7 Participants	98 Participants n=5 Participants
Estrogen Receptor/Progesterone Receptor Status at Last Biopsy ER/PgR Negative	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Estrogen Receptor/Progesterone Receptor Status at Last Biopsy Unknown	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Time since Initial Brain Metastasis Diagnosis	1.137 years STANDARD_DEVIATION 1.1061 • n=5 Participants	1.194 years STANDARD_DEVIATION 1.1748 • n=7 Participants	1.165 years STANDARD_DEVIATION 1.1369 • n=5 Participants

PRIMARY outcome

Timeframe: Within 3 years from study start

To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis.

Outcome measures

Measure	NKTR-102 n=92 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=86 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Overall Survival (OS) of Patients	7.8 months Interval 6.1 to 10.2	7.5 months Interval 5.8 to 10.4

SECONDARY outcome

Timeframe: Through study completion, an expected average of 1 year

Progression-Free Survival (PFS) is defined as the time from the date of randomization to the earliest evidence of documented Progressive Disease (PD) or of death from any cause. The date of global deterioration or symptomatic deterioration will not be used as the date of PD. The assessment of PFS outside the CNS will utilize RECIST criteria v1.1.

Outcome measures

Measure	NKTR-102 n=92 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=86 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Progression-Free Survival (Outside the Central Nervous System)	2.8 months Interval 2.0 to 4.1	1.9 months Interval 1.9 to 2.1

SECONDARY outcome

Timeframe: Through study completion, an expected average of 1 year

Progression-Free Survival in Brain Metastasis (PFS-BM) is defined as the time from the date of randomization to the earliest evidence of documented Progressive Disease (PD) per Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) in brain metastases or death from any cause. The PD will also be determined by the investigator's assessments. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameters of CNS target lesions, taking as reference the smallest sum on study. This included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, at least 1 lesion had to increase by an absolute value of 5 mm or more to be considered progression.

Outcome measures

Measure	NKTR-102 n=92 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=86 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Progression-Free Survival in Brain Metastasis (PFS-BM)	3.9 months Interval 2.6 to 4.3	3.3 months Interval 1.9 to 3.7

SECONDARY outcome

Timeframe: Through study completion, an expected average of 1 year

Progression-free survival (CNS and peripheral) is defined as the time from the date of randomization to the earliest evidence of documented PD in either the CNS or peripheral (using RANO-BM) or death from any cause. The PD will be determined by both the investigator's and the central imaging facility assessments. The same statistical methods that were used for PFS and PFS-BM will be used for PFS (Overall). Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameters of CNS target lesions, taking as reference the smallest sum on study. This included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, at least 1 lesion had to increase by an absolute value of 5 mm or more to be considered progression.

Outcome measures

Measure	NKTR-102 n=92 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=86 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Progression-Free Survival (Overall)	2.1 months Interval 1.9 to 3.7	1.9 months Interval 1.8 to 2.0

SECONDARY outcome

Timeframe: Through study completion, an expected average of 1 year

Population: 156 patients had measurable disease by RECIST v 1.1 at baseline and were included in the Response Evaluable population for this outcome.

RECIST criteria for lesions outside the Central Nervous System (CNS); RANO-BM criteria for CNS lesions) based upon the best response as assessed by the central imaging facility. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	NKTR-102 n=83 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=73 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Objective Response Rates (ORR) of the NKTR-102 Treatment and the Treatment of Physician's Choice (TPC) Objective Response Rate (CR+PR)	4 Participants	2 Participants
Objective Response Rates (ORR) of the NKTR-102 Treatment and the Treatment of Physician's Choice (TPC) Stable Disease	16 Participants	5 Participants
Objective Response Rates (ORR) of the NKTR-102 Treatment and the Treatment of Physician's Choice (TPC) Progressive Disease	38 Participants	32 Participants
Objective Response Rates (ORR) of the NKTR-102 Treatment and the Treatment of Physician's Choice (TPC) Not Evaluable	18 Participants	30 Participants
Objective Response Rates (ORR) of the NKTR-102 Treatment and the Treatment of Physician's Choice (TPC) Missing	7 Participants	4 Participants

SECONDARY outcome

Timeframe: For at least 4 months, with an expected average of 1 year

Clinical Benefit Rate will be defined as the proportion of patients having a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for at least 4 months (≥ 120 days). CR is defined as disappearance of all target lesions for at least 4 weeks with no new lesions, not use of corticosteroids, and patient was stable or improved clinically. PR is defined as at least a 30% decrease in the sum of longest diameters sustained for at least 4 weeks, no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	NKTR-102 n=92 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=86 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Clinical Benefit Rate (CBR) # of Patients who achieved Complete Response	0 participants	0 participants
Clinical Benefit Rate (CBR) # of Patients who achieved Partial Response	6 participants	6 participants
Clinical Benefit Rate (CBR) # of Patients who have Stable Disease >= 120 days	17 participants	5 participants
Clinical Benefit Rate (CBR) # of Patients who achieved Clinical Benefit Rate (CBR)	23 participants	11 participants

SECONDARY outcome

Timeframe: Through study completion, an expected average of 1 year

Duration of response (DoR) outside the CNS will be defined as the time from first documented CR or PR until the earliest evidence of disease progression per RECIST v1.1 or death from any cause. CR is defined as disappearance of all target lesions for at least 4 weeks with no new lesions, not use of corticosteroids, and patient was stable or improved clinically. PR is defined as at least a 30% decrease in the sum of longest diameters sustained for at least 4 weeks, no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	NKTR-102 n=83 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=73 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Duration of Response (DoR)	7.4 months Interval 7.3 to 16.4	3.5 months Interval 3.5 to 3.5

SECONDARY outcome

Timeframe: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 for NKTR-102 or 28 days for TPC] and end of Cycle 44.

Population: As the trial progressed, some patients discontinued study treatment as a result of progressive disease, non-PD AE, patient decision, or physician decision.

The EORTC QLQ-BN20 Scale has a series of 20 questions each of which involve reporting a scale from 1-4. It is an increasing scale where a score of one indicates "not at all" while a score of four indicates "very much". The minimum score is 20 and the maximum score is 80. The higher the score the worse the outcome.

Outcome measures

Measure	NKTR-102 n=79 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=63 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Compare Health-Related Quality of Life (HRQoL) Using the European Organisation for Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) Module With the Brain Neoplasms 20-question (BN-20) Subscale. QLQ-C30 Score at Baseline	57.59 Units on a Scale Standard Deviation 21.607	52.25 Units on a Scale Standard Deviation 24.236
Compare Health-Related Quality of Life (HRQoL) Using the European Organisation for Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) Module With the Brain Neoplasms 20-question (BN-20) Subscale. QLQ-C30 Score at End of Treatment, approximately 1 year	46.97 Units on a Scale Standard Deviation 24.582	52.38 Units on a Scale Standard Deviation 24.801

SECONDARY outcome

Timeframe: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 for NKTR-102 or 28 days for TPC] and end of Cycle 44

Population: As the trial progressed, some patients discontinued study treatment as a result of progressive disease, non-PD AE, patient decision, or physician decision.

The EQ-5D-5L scale is used to measure health by having a patient answer a series of questions. There are a series of 5 questions each of which is scaled from a score of 4-20 in increasing increments of 4. The scale is numbered from 0 to 100 where 100 means the beast health you can imagine and 0 means the worst health.

Outcome measures

Measure	NKTR-102 n=80 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=63 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Compare Health-Related Quality of Life (HRQoL) Using the the EuroQoL 5D (EQ-5D-5L™) EQ-5D-5L Score at End of Treatment, approximately 1 year	56.53 Units on a Scale Standard Deviation 23.467	61.60 Units on a Scale Standard Deviation 20.858
Compare Health-Related Quality of Life (HRQoL) Using the the EuroQoL 5D (EQ-5D-5L™) EQ-5D-5L Score at Baseline	61.41 Units on a Scale Standard Deviation 19.739	60.33 Units on a Scale Standard Deviation 23.004

SECONDARY outcome

Timeframe: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 for NKTR-102 or 28 days for TPC] and end of Cycle 44

Population: As the trial progressed, some patients discontinued study treatment as a result of progressive disease, non-PD AE, patient decision, or physician decision.

The Brief Fatigue Inventory scale utilizes a series of 4 questions. The first three are scored with a scale from 1-10. The fourth question has 6 six sub components each of which are scored with a scale of 1-10. For every scale, a score of 0 indicates no fatigue/interference where a score of 10 indicates as bad as you can imagine. A patient's score can range from 0 to 100 where 0 indicates the best outcome and 100 indicates the worst.

Outcome measures

Measure	NKTR-102 n=79 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=62 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Compare Health-Related Quality of Life (HRQoL) Using the Brief Fatigue Inventory (BFI) BFI Score at Baseline	4.18 Units on a Scale Standard Deviation 2.264	4.04 Units on a Scale Standard Deviation 2.401
Compare Health-Related Quality of Life (HRQoL) Using the Brief Fatigue Inventory (BFI) BFI Score at End of Treatment, approximately 1 year	4.83 Units on a Scale Standard Deviation 2.476	4.74 Units on a Scale Standard Deviation 2.373

SECONDARY outcome

Timeframe: Through study completion, within 3 years from study start

The magnitude of clinical benefit of NKTR-102 is assessed by the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) (v1.0). The scale is graded 5, 4, 3, 2, 1, where grades 5 and 4 represent a high level of proven clinical benefit, and grade 1 represents no clinical benefit. To determine the magnitude of clinical benefit when the median OS with the standard of treatment is ≤ 1 year, the score is derived from the Hazard Ratio (HR) of Overall Survival, overall survival gain, and QoL improvement between two treatment arms. Values reported in the data table are Overall Survival values.

Outcome measures

Measure	NKTR-102 n=92 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=86 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Magnitude of Clinical Benefit Assessed by ESMO-MCBS Derived From Overall Survival	7.8 months Interval 6.1 to 10.2	7.5 months Interval 5.8 to 10.4

SECONDARY outcome

Timeframe: Through study completion, an expected average of 1 year

Population: 167 patients received at least one dose of study treatment and were included in the Safety population for this outcome.

The number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3

Outcome measures

Measure	NKTR-102 n=90 Participants In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=77 Participants In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3	90 Participants	76 Participants

Adverse Events

NKTR-102

Serious events: 33 serious events

Other events: 90 other events

Deaths: 2 deaths

Treatment of Physician's Choice (TPC)

Serious events: 24 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Measure	NKTR-102 n=90 participants at risk In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=77 participants at risk In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Musculoskeletal and connective tissue disorders Back Pain Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Dizziness Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Epilepsy Grade 2	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Fine motor skill dysfunction Grade 2	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Hypoesthesia Grade 2	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Paresthesia Grade 2	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Seizure Grade 2	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Syncope Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Status Epilepticus Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Psychiatric disorders Confusional State Grade 2	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Psychiatric disorders Confusional State Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Psychiatric disorders Mental Status Changes Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Psychiatric disorders Hallucination Grade 4	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Respiratory, thoracic and mediastinal disorders Pleural Effusion Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Respiratory, thoracic and mediastinal disorders Pneumothorax Grade 2	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Respiratory, thoracic and mediastinal disorders Dyspnea Grade 2	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Respiratory, thoracic and mediastinal disorders Dyspnea Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Vascular disorders Deep Vein Thrombosis Grade 4	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Influenza Grade 4	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Cellulitis Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Device Related Sepsis Grade 4	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Lung Infection Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Escherichia Sepsis Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Pyoderma Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Injury, poisoning and procedural complications Fall Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Investigations Neutrophil Count Decrease Grade 4	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Metabolism and nutrition disorders Failure to Thrive Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Metabolism and nutrition disorders Hypercalcemia Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Groin Pain Grade 2	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Muscle Spasm Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Colitis Grade 2	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Brain Edema Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Immune system disorders Leukopenia Grade 4	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Immune system disorders Neutropenia Grade 4	3.3% 3/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Esophagitis Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Pneumonia Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Device Related Infection Grade 4	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Neutropenic Sepsis Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Metabolism and nutrition disorders Hyponatremia Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Pathological Fracture Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Malaise Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Cardiac disorders Atrial Fibrillation Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Viral Gastroenteritis Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Vomiting Grade 2	3.3% 3/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Diarrhea Grade 3	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Metabolism and nutrition disorders Dehydration Grade 3	2.2% 2/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Hip Fracture Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	2.6% 2/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Urinary Tract Infection Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Intestinal Obstruction Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Nausea Grade 2	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Fatigue Grade 2	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Abdominal Pain Grade 2	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Dysphagia Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Esophageal Candidiasis Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Bacteremia Grade 4	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Contusion Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Hepatobiliary disorders Hyperbilirubinemia	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	2.6% 2/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Blood and lymphatic system disorders Febrile Neutropenia Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Immune system disorders Normochromic normocytic Anemia Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Cardiac disorders Cardiac Tamponade Grade 4	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Eye disorders Blindness Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Colitis Grade 3	3.3% 3/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Vomiting Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Neutropenic Colitis Grade 4	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Abdominal Pain Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Generalized Physical Health Deterioration Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Generalized Physical Health Deterioration Grade 5	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Asthenia Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Fatigue Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Hepatobiliary disorders Bile Duct Stone Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Hepatobiliary disorders Cholecystitis Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Hepatobiliary disorders Hepatic Function Abnormal Grade 3	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Hepatobiliary disorders Hepatic Failure Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Hepatobiliary disorders Hyperbilirubinemia Grade 3	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	2.6% 2/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Pneumonia Grade 5	1.1% 1/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.

Other adverse events

Measure	NKTR-102 n=90 participants at risk In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.	Treatment of Physician's Choice (TPC) n=77 participants at risk In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Metabolism and nutrition disorders Hypocalcemia	8.9% 8/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Nausea	60.0% 54/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	40.3% 31/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Diarrhea	73.3% 66/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	19.5% 15/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Vomiting	37.8% 34/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	22.1% 17/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Constipation	26.7% 24/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	26.0% 20/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Abdominal Pain	21.1% 19/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	14.3% 11/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Upper Abdominal Pain	6.7% 6/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	3.9% 3/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Stomatitis	4.4% 4/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	6.5% 5/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Stomatitis	4.4% 4/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	6.5% 5/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Abdominal Distension	7.8% 7/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Flatulence	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Dyspepsia	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	0.00% 0/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Fatigue	40.0% 36/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	33.8% 26/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Asthenia	31.1% 28/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	20.8% 16/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Pyrexia	6.7% 6/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	9.1% 7/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Gastrointestinal disorders Oedema Peripheral	6.7% 6/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	6.5% 5/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
General disorders Pain	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	5.2% 4/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Metabolism and nutrition disorders Decreased Appetite	36.7% 33/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	18.2% 14/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Metabolism and nutrition disorders Hypokalemia	17.8% 16/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	5.2% 4/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Metabolism and nutrition disorders Dehydration	10.0% 9/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Metabolism and nutrition disorders Hypoalbuminemia	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	11.7% 9/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Pain in Extremity	6.7% 6/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	10.4% 8/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Back Pain	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	9.1% 7/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Muscle Spasms	8.9% 8/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	2.6% 2/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Myalgia	2.2% 2/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	10.4% 8/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Muscle Weakness	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	3.9% 3/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Bone Pain	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	5.2% 4/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Headache	20.0% 18/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	11.7% 9/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Dizziness	10.0% 9/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	5.2% 4/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Neuropathy Peripheral	3.3% 3/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	11.7% 9/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Dygeusia	7.8% 7/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	2.6% 2/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Nervous system disorders Seizure	2.2% 2/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	5.2% 4/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Blood and lymphatic system disorders Neutropenia	18.9% 17/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	23.4% 18/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Blood and lymphatic system disorders Anemia	12.2% 11/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	22.1% 17/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Blood and lymphatic system disorders Thrombocytopenia	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	6.5% 5/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Blood and lymphatic system disorders Leukopenia	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	3.9% 3/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Investigations Neutrophil Count Decreased	6.7% 6/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	13.0% 10/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Investigations Aspartate Aminotransferase Increased	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	11.7% 9/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Investigations Weight Decreased	14.4% 13/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Investigations Alanine Aminotransferase Increased	2.2% 2/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	11.7% 9/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Investigations Platelet Count Decresed	3.3% 3/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	5.2% 4/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Investigations White Blood Cell Count Decreased	2.2% 2/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	5.2% 4/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.2% 11/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	18.2% 14/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 9/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	9.1% 7/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	5.6% 5/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	1.3% 1/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Skin and subcutaneous tissue disorders Alopecia	11.1% 10/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	11.7% 9/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Skin and subcutaneous tissue disorders Pruritus	6.7% 6/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	5.2% 4/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Skin and subcutaneous tissue disorders Rash	3.3% 3/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	6.5% 5/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Infections and infestations Urinary Tract Infection	8.9% 8/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	3.9% 3/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Psychiatric disorders Insomnia	8.9% 8/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	6.5% 5/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Psychiatric disorders Anxiety	2.2% 2/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	7.8% 6/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Psychiatric disorders Depression	6.7% 6/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	2.6% 2/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.
Eye disorders Vision Blurred	11.1% 10/90 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.	2.6% 2/77 • The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months. 167 patients received at least one dose of study treatment and were included in the Safety population.

Additional Information

Study Director

Nektar Therapeutics

Phone: 855-482-8676

Email: StudyInquiry@nektar.com

Results disclosure agreements

• Principal investigator is a sponsor employee There are restrictions to the PI's rights to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER