Trial Outcomes & Findings for The BEACON Study (Breast Cancer Outcomes With NKTR-102) (NCT NCT01492101)
NCT ID: NCT01492101
Last Updated: 2021-06-01
Results Overview
Duration of OS was defined as the time from the date of randomisation to the date of death due to any cause. Subjects were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. OS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. Subjects who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Subjects who did not have any follow-up since the date of randomization were censored at the date of randomization.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
852 participants
Primary outcome timeframe
36 Months
Results posted on
2021-06-01
Participant Flow
Participant milestones
| Measure |
NKTR-102
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Overall Study
STARTED
|
429
|
423
|
|
Overall Study
COMPLETED
|
92
|
81
|
|
Overall Study
NOT COMPLETED
|
337
|
342
|
Reasons for withdrawal
| Measure |
NKTR-102
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Overall Study
Death
|
323
|
322
|
|
Overall Study
Withdrawal by Subject
|
14
|
18
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
The BEACON Study (Breast Cancer Outcomes With NKTR-102)
Baseline characteristics by cohort
| Measure |
NKTR-102
n=429 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=423 Participants
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
Total
n=852 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
341 Participants
n=5 Participants
|
342 Participants
n=7 Participants
|
683 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
88 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
429 Participants
n=5 Participants
|
423 Participants
n=7 Participants
|
852 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
15 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
43 participants
n=5 Participants
|
42 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
53 participants
n=5 Participants
|
39 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
198 participants
n=5 Participants
|
180 participants
n=7 Participants
|
378 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
19 participants
n=5 Participants
|
23 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
France
|
36 participants
n=5 Participants
|
47 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
46 participants
n=5 Participants
|
51 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
14 participants
n=5 Participants
|
9 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 MonthsDuration of OS was defined as the time from the date of randomisation to the date of death due to any cause. Subjects were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. OS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. Subjects who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Subjects who did not have any follow-up since the date of randomization were censored at the date of randomization.
Outcome measures
| Measure |
NKTR-102
n=429 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=423 Participants
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population
|
12.4 Months
Interval 11.0 to 13.6
|
10.3 Months
Interval 9.0 to 11.3
|
SECONDARY outcome
Timeframe: Up to 38 months.PFS was defined as the time from the date of randomization to the earliest date of disease progression (assessed by the investigator according to RECIST version 1.1) or death due to any cause. PFS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. For subjects whose disease did not progress or who did not die, the PFS time was censored at the time of the last tumor assessment that demonstrated lack of disease progression. For subjects who received new anti-cancer therapy, the PFS time was censored at the start of the new anti-cancer therapy.
Outcome measures
| Measure |
NKTR-102
n=429 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=423 Participants
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population
|
2.4 Months
Interval 2.1 to 3.5
|
2.8 Months
Interval 2.1 to 3.5
|
SECONDARY outcome
Timeframe: Up to 38 months.CBR was defined as the proportion of subjects with a CR, PR, or stable disease (SD) for at least 6 months (≥ 182 days).
Outcome measures
| Measure |
NKTR-102
n=429 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=423 Participants
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Clinical Benefit Rate (CBR): ITT Population
|
20.5 percentage of subjects
Interval 16.8 to 24.6
|
19.6 percentage of subjects
Interval 15.9 to 23.7
|
SECONDARY outcome
Timeframe: Up to 38 months.Population: The population analyzed for this outcome measure solely comprised of patients who achieved CR or PR per RECIST.
DOR was defined as the time from first documented CR or PR until the earliest evidence of disease progression or death from any cause. Subjects who were alive without documented disease progression per RECIST version 1.1 were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease.
Outcome measures
| Measure |
NKTR-102
n=58 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=61 Participants
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Duration of Response (DOR): Efficacy Evaluable Population
|
3.9 Months
Interval 3.5 to 5.1
|
3.7 Months
Interval 2.1 to 3.9
|
SECONDARY outcome
Timeframe: Up to 38 months.Proportion of subjects who had a reduction in dose.
Outcome measures
| Measure |
NKTR-102
n=425 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=406 Participants
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Incidence of Dose Reductions: Safety Population
|
27.5 percentage of subjects
|
28.3 percentage of subjects
|
SECONDARY outcome
Timeframe: Up to 39 monthsPopulation: 429 (ITT Population) 423 (ITT Population)
The QLQ-C30 is composed of 5 multi-item functional scales (physical, role, social, emotional and cognitive functioning), a global health status/QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (financial impact, appetite loss, diarrhoea, constipation, insomnia and dyspnoea). Most items are scaled 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) except the items contributing to the global health status/QoL, which are 7-point questions (1 = very poor to 7 = excellent). Raw scores were transformed using a linear transformation to standardize the results so that scores range from 0 to 100. n=number of subjects who completed each individual scale. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.
Outcome measures
| Measure |
NKTR-102
n=429 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=423 Participants
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Fatigue
|
37.7 units on a scale
Standard Deviation 23.68
|
41.3 units on a scale
Standard Deviation 22.98
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Global health status/QoL
|
61.4 units on a scale
Standard Deviation 21.76
|
58.0 units on a scale
Standard Deviation 20.43
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Physical functioning
|
74.5 units on a scale
Standard Deviation 19.72
|
72.3 units on a scale
Standard Deviation 19.74
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Role functioning
|
71.8 units on a scale
Standard Deviation 26.81
|
67.3 units on a scale
Standard Deviation 26.93
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Emotional functioning
|
72.4 units on a scale
Standard Deviation 21.86
|
71.9 units on a scale
Standard Deviation 20.06
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Cognitive functioning
|
82.5 units on a scale
Standard Deviation 18.7
|
81.2 units on a scale
Standard Deviation 19.04
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Social functioning
|
73.0 units on a scale
Standard Deviation 26.69
|
71.0 units on a scale
Standard Deviation 25.06
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Nausea and vomiting
|
8.6 units on a scale
Standard Deviation 13.39
|
9.9 units on a scale
Standard Deviation 16.17
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Pain
|
32.3 units on a scale
Standard Deviation 27.2
|
35.3 units on a scale
Standard Deviation 28.01
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Dyspnoea
|
24.5 units on a scale
Standard Deviation 27.44
|
23.6 units on a scale
Standard Deviation 26.2
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Insomnia
|
29.3 units on a scale
Standard Deviation 28.94
|
31.5 units on a scale
Standard Deviation 27.11
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Appetite loss
|
24.3 units on a scale
Standard Deviation 27.55
|
26.6 units on a scale
Standard Deviation 27.89
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Constipation
|
18.0 units on a scale
Standard Deviation 25.9
|
21.0 units on a scale
Standard Deviation 28.15
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Diarrhoea
|
6.3 units on a scale
Standard Deviation 13.64
|
5.6 units on a scale
Standard Deviation 11.14
|
|
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
Financial difficulties
|
26.4 units on a scale
Standard Deviation 31.29
|
21.9 units on a scale
Standard Deviation 28.95
|
SECONDARY outcome
Timeframe: From Baseline to Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56.Population: 429 (ITT Population) 423 (ITT Population)
The QLQ-C30 is composed of 5 multi-item functional scales (physical, role, social, emotional and cognitive functioning), a global health status/QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (financial impact, appetite loss, diarrhea, constipation, insomnia and dyspnea). Most items are scaled 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) except the items contributing to the global health status/QoL, which are 7-point questions (from 1 = very poor to 7 = excellent). Raw scores were transformed using a linear transformation to standardize the results so that scores range from 0 to 100. n=number of subjects who completed each individual scale. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.
Outcome measures
| Measure |
NKTR-102
n=429 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=423 Participants
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Role functioning: Week 56
|
-2.6 units on a scale
Standard Deviation 17.12
|
-9.4 units on a scale
Standard Deviation 35.08
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Emotional functioning: Week 8
|
-0.5 units on a scale
Standard Deviation 19.65
|
-2.0 units on a scale
Standard Deviation 19.95
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Cognitive functioning: Week 24
|
-1.8 units on a scale
Standard Deviation 17.26
|
-2.2 units on a scale
Standard Deviation 17.12
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Cognitive functioning: Week 56
|
-2.9 units on a scale
Standard Deviation 18.25
|
-6.7 units on a scale
Standard Deviation 22.97
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Social functioning: Week 32
|
-8.8 units on a scale
Standard Deviation 20.61
|
-7.2 units on a scale
Standard Deviation 30.1
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Social functioning: Week 56
|
-3.2 units on a scale
Standard Deviation 22.25
|
-24.4 units on a scale
Standard Deviation 29.96
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Fatigue: Week 56
|
2.1 units on a scale
Standard Deviation 19.57
|
4.5 units on a scale
Standard Deviation 24.36
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Nausea and vomiting: Week 56
|
8.0 units on a scale
Standard Deviation 11.66
|
1.6 units on a scale
Standard Deviation 23.02
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Pain: Week 40
|
1.6 units on a scale
Standard Deviation 31.82
|
1.3 units on a scale
Standard Deviation 29.96
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Dyspnoea: Week 8
|
0.7 units on a scale
Standard Deviation 25.02
|
5.8 units on a scale
Standard Deviation 24.59
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Dyspnoea: Week 24
|
-2.0 units on a scale
Standard Deviation 25.65
|
1.4 units on a scale
Standard Deviation 20.47
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Dyspnoea: Week 32
|
0 units on a scale
Standard Deviation 24.77
|
8.6 units on a scale
Standard Deviation 29.67
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Dyspnoea: Week 56
|
-7.1 units on a scale
Standard Deviation 18.36
|
-1.2 units on a scale
Standard Deviation 22.13
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Appetite loss: Week 24
|
4.6 units on a scale
Standard Deviation 36.55
|
-1.6 units on a scale
Standard Deviation 30.57
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Appetite loss: Week 32
|
8.9 units on a scale
Standard Deviation 35.42
|
0 units on a scale
Standard Deviation 32.04
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Appetite loss: Week 56
|
14.7 units on a scale
Standard Deviation 35.38
|
1.0 units on a scale
Standard Deviation 39.19
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Constipation: Week 24
|
0.5 units on a scale
Standard Deviation 29.65
|
-2.0 units on a scale
Standard Deviation 28.14
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Constipation: Week 32
|
4.6 units on a scale
Standard Deviation 29.83
|
0.3 units on a scale
Standard Deviation 26.53
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Constipation: Week 40
|
1.0 units on a scale
Standard Deviation 28.44
|
-3.2 units on a scale
Standard Deviation 29.32
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Constipation: Week 48
|
-0.6 units on a scale
Standard Deviation 31.65
|
7.0 units on a scale
Standard Deviation 33.48
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Diarrhoea: Week 8
|
10.2 units on a scale
Standard Deviation 27.98
|
1.8 units on a scale
Standard Deviation 16.87
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Diarrhoea: Week 32
|
9.2 units on a scale
Standard Deviation 21.3
|
0.8 units on a scale
Standard Deviation 17.07
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Diarrhoea: Week 40
|
8.3 units on a scale
Standard Deviation 23.06
|
7.8 units on a scale
Standard Deviation 27.93
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Financial difficulties: Week 24
|
1.0 units on a scale
Standard Deviation 21.09
|
4.6 units on a scale
Standard Deviation 28.38
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Financial difficulties: Week 40
|
4.2 units on a scale
Standard Deviation 21.61
|
-1.7 units on a scale
Standard Deviation 19.74
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Global health status/QoL: Week 8
|
-4.4 units on a scale
Standard Deviation 22.57
|
-4.7 units on a scale
Standard Deviation 20.37
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Global health status/QoL: Week 16
|
-2.5 units on a scale
Standard Deviation 22.9
|
-5.6 units on a scale
Standard Deviation 21.86
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Global health status/QoL: Week 24
|
-1.8 units on a scale
Standard Deviation 24.99
|
-6.6 units on a scale
Standard Deviation 22.47
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Global health status/QoL: Week 32
|
-0.2 units on a scale
Standard Deviation 20.39
|
-6.3 units on a scale
Standard Deviation 26.66
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Global health status/QoL: Week 40
|
-5.2 units on a scale
Standard Deviation 22.27
|
-2.6 units on a scale
Standard Deviation 19.41
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Global health status/QoL: Week 48
|
-2.3 units on a scale
Standard Deviation 18.62
|
-1.8 units on a scale
Standard Deviation 20.71
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Global health status/QoL: Week 56
|
2.9 units on a scale
Standard Deviation 17.79
|
-11.1 units on a scale
Standard Deviation 29.36
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Physical functioning: Week 8
|
-4.9 units on a scale
Standard Deviation 17.98
|
-7.1 units on a scale
Standard Deviation 17.4
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Physical functioning: Week 16
|
-3.0 units on a scale
Standard Deviation 20.63
|
-7.0 units on a scale
Standard Deviation 18.26
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Physical functioning: Week 24
|
0.3 units on a scale
Standard Deviation 20.93
|
-4.7 units on a scale
Standard Deviation 15.9
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Physical functioning: Week 32
|
-3.0 units on a scale
Standard Deviation 18.88
|
-8.5 units on a scale
Standard Deviation 20.4
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Physical functioning: Week 40
|
-1.9 units on a scale
Standard Deviation 19.23
|
-6.4 units on a scale
Standard Deviation 18.81
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Physical functioning: Week 48
|
0.2 units on a scale
Standard Deviation 17.66
|
-7.4 units on a scale
Standard Deviation 16.46
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Physical functioning: Week 56
|
2.2 units on a scale
Standard Deviation 13.48
|
-10.4 units on a scale
Standard Deviation 24.27
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Role functioning: Week 8
|
-6.6 units on a scale
Standard Deviation 27.26
|
-8.3 units on a scale
Standard Deviation 27.37
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Role functioning: Week 16
|
-4.8 units on a scale
Standard Deviation 26.06
|
-8.3 units on a scale
Standard Deviation 24.41
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Role functioning: Week 24
|
-7.8 units on a scale
Standard Deviation 33.3
|
-10.8 units on a scale
Standard Deviation 26.72
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Role functioning: Week 32
|
-9.7 units on a scale
Standard Deviation 19.03
|
-12.2 units on a scale
Standard Deviation 29.81
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Role functioning: Week 40
|
-8.7 units on a scale
Standard Deviation 30.94
|
-7.8 units on a scale
Standard Deviation 27.93
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Role functioning: Week 48
|
-3.1 units on a scale
Standard Deviation 25.38
|
-5.7 units on a scale
Standard Deviation 21.7
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Emotional functioning: Week 16
|
2.7 units on a scale
Standard Deviation 18.93
|
-1.6 units on a scale
Standard Deviation 20.57
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Emotional functioning: Week 24
|
-0.6 units on a scale
Standard Deviation 22.34
|
-3.7 units on a scale
Standard Deviation 18.95
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Emotional functioning: Week 32
|
-2.8 units on a scale
Standard Deviation 21.02
|
-7.6 units on a scale
Standard Deviation 20.88
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Emotional functioning: Week 40
|
-1.4 units on a scale
Standard Deviation 26.12
|
0.8 units on a scale
Standard Deviation 19.11
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Emotional functioning: Week 48
|
0.9 units on a scale
Standard Deviation 21.37
|
1.2 units on a scale
Standard Deviation 18.83
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Emotional functioning: Week 56
|
-3.6 units on a scale
Standard Deviation 19.72
|
-4.7 units on a scale
Standard Deviation 25.29
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Cognitive functioning: Week 8
|
-3.3 units on a scale
Standard Deviation 18.46
|
-3.2 units on a scale
Standard Deviation 19.44
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Cognitive functioning: Week 16
|
-1.4 units on a scale
Standard Deviation 17.67
|
-4.4 units on a scale
Standard Deviation 20.81
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Cognitive functioning: Week 32
|
-4.6 units on a scale
Standard Deviation 17.82
|
-7.9 units on a scale
Standard Deviation 20.14
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Cognitive functioning: Week 40
|
-5.7 units on a scale
Standard Deviation 18.61
|
-3.5 units on a scale
Standard Deviation 21.6
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Cognitive functioning: Week 48
|
-4.6 units on a scale
Standard Deviation 18.04
|
2.2 units on a scale
Standard Deviation 17.75
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Social functioning: Week 8
|
-4.9 units on a scale
Standard Deviation 27.46
|
-6.2 units on a scale
Standard Deviation 24.04
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Social functioning: Week 16
|
0.4 units on a scale
Standard Deviation 27.57
|
-6.4 units on a scale
Standard Deviation 24.2
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Social functioning: Week 24
|
-3.4 units on a scale
Standard Deviation 25.68
|
-7.2 units on a scale
Standard Deviation 24.1
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Social functioning: Week 40
|
-9.7 units on a scale
Standard Deviation 26.09
|
-7.0 units on a scale
Standard Deviation 20.98
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Social functioning: Week 48
|
-5.5 units on a scale
Standard Deviation 17.86
|
-6.6 units on a scale
Standard Deviation 20.71
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Fatigue: Week 8
|
6.7 units on a scale
Standard Deviation 22.88
|
6.6 units on a scale
Standard Deviation 22.17
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Fatigue: Week 16
|
3.7 units on a scale
Standard Deviation 22.63
|
7.7 units on a scale
Standard Deviation 22.84
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Fatigue: Week 24
|
3.0 units on a scale
Standard Deviation 26.51
|
3.6 units on a scale
Standard Deviation 21.23
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Fatigue: Week 32
|
5.0 units on a scale
Standard Deviation 21.84
|
6.6 units on a scale
Standard Deviation 24.25
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Fatigue: Week 40
|
4.1 units on a scale
Standard Deviation 26.65
|
2.3 units on a scale
Standard Deviation 19.02
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Fatigue: Week 48
|
0.9 units on a scale
Standard Deviation 18.69
|
6.7 units on a scale
Standard Deviation 14.53
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Nausea and vomiting: Week 8
|
12.8 units on a scale
Standard Deviation 23.28
|
4.2 units on a scale
Standard Deviation 21.94
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Nausea and vomiting: Week 16
|
8.8 units on a scale
Standard Deviation 19.85
|
-2.0 units on a scale
Standard Deviation 19.1
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Nausea and vomiting: Week 24
|
7.2 units on a scale
Standard Deviation 22.57
|
-0.1 units on a scale
Standard Deviation 16.55
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Nausea and vomiting: Week 32
|
6.5 units on a scale
Standard Deviation 14.21
|
3.5 units on a scale
Standard Deviation 18.81
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Nausea and vomiting: Week 40
|
4.5 units on a scale
Standard Deviation 12.97
|
5.6 units on a scale
Standard Deviation 23.61
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Nausea and vomiting: Week 48
|
5.0 units on a scale
Standard Deviation 13.77
|
3.9 units on a scale
Standard Deviation 28.92
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Pain: Week 8
|
-1.7 units on a scale
Standard Deviation 26.08
|
2.4 units on a scale
Standard Deviation 27.03
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Pain: Week 16
|
-5.0 units on a scale
Standard Deviation 26.9
|
1.9 units on a scale
Standard Deviation 27.8
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Pain: Week 24
|
-4.1 units on a scale
Standard Deviation 29.35
|
2.1 units on a scale
Standard Deviation 27.78
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Pain: Week 32
|
-1.0 units on a scale
Standard Deviation 27.17
|
3.9 units on a scale
Standard Deviation 32.49
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Pain: Week 48
|
-0.8 units on a scale
Standard Deviation 30.82
|
-0.4 units on a scale
Standard Deviation 25.23
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Pain: Week 56
|
-4.2 units on a scale
Standard Deviation 22.88
|
0.5 units on a scale
Standard Deviation 33.95
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Dyspnoea: Week 16
|
-1.1 units on a scale
Standard Deviation 26.34
|
4.6 units on a scale
Standard Deviation 26.99
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Dyspnoea: Week 40
|
2.4 units on a scale
Standard Deviation 27.93
|
5.0 units on a scale
Standard Deviation 25.95
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Dyspnoea: Week 48
|
-5.6 units on a scale
Standard Deviation 26.38
|
-0.9 units on a scale
Standard Deviation 19.62
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Insomnia: Week 8
|
-1.5 units on a scale
Standard Deviation 28.1
|
3.3 units on a scale
Standard Deviation 30.28
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Insomnia: Week 16
|
-1.4 units on a scale
Standard Deviation 24.4
|
2.1 units on a scale
Standard Deviation 27.2
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Insomnia: Week 24
|
-2.7 units on a scale
Standard Deviation 31.77
|
1.3 units on a scale
Standard Deviation 26.41
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Insomnia: Week 32
|
1.5 units on a scale
Standard Deviation 34.04
|
2.5 units on a scale
Standard Deviation 30.14
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Insomnia: Week 40
|
0 units on a scale
Standard Deviation 31.51
|
4.4 units on a scale
Standard Deviation 22.71
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Insomnia: Week 48
|
2.8 units on a scale
Standard Deviation 28.05
|
0.9 units on a scale
Standard Deviation 34.01
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Insomnia: Week 56
|
-1.3 units on a scale
Standard Deviation 35.57
|
-1.0 units on a scale
Standard Deviation 27.53
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Appetite loss: Week 8
|
11.6 units on a scale
Standard Deviation 32.03
|
4.0 units on a scale
Standard Deviation 30.26
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Appetite loss: Week 16
|
9.4 units on a scale
Standard Deviation 32.16
|
-2.1 units on a scale
Standard Deviation 29.75
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Appetite loss: Week 40
|
6.9 units on a scale
Standard Deviation 38.57
|
5.4 units on a scale
Standard Deviation 38.58
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Appetite loss: Week 48
|
2.2 units on a scale
Standard Deviation 34.67
|
13.0 units on a scale
Standard Deviation 45.93
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Constipation: Week 8
|
2.1 units on a scale
Standard Deviation 29.95
|
6.7 units on a scale
Standard Deviation 27.81
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Constipation: Week 16
|
0.2 units on a scale
Standard Deviation 31.03
|
3.1 units on a scale
Standard Deviation 30.96
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Constipation: Week 56
|
1.9 units on a scale
Standard Deviation 34.42
|
-4.4 units on a scale
Standard Deviation 35.34
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Diarrhoea: Week 16
|
10.8 units on a scale
Standard Deviation 26.97
|
3.4 units on a scale
Standard Deviation 19.07
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Diarrhoea: Week 24
|
9.4 units on a scale
Standard Deviation 26.43
|
2.4 units on a scale
Standard Deviation 16.39
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Diarrhoea: Week 48
|
12.1 units on a scale
Standard Deviation 22.23
|
0 units on a scale
Standard Deviation 17.57
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Diarrhoea: Week 56
|
4.5 units on a scale
Standard Deviation 14.57
|
6.7 units on a scale
Standard Deviation 31.37
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Financial difficulties: Week 8
|
-0.7 units on a scale
Standard Deviation 22.87
|
0.6 units on a scale
Standard Deviation 22.42
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Financial difficulties: Week 16
|
0.8 units on a scale
Standard Deviation 23.26
|
1.0 units on a scale
Standard Deviation 22.48
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Financial difficulties: Week 32
|
1.2 units on a scale
Standard Deviation 20.28
|
10.2 units on a scale
Standard Deviation 26.81
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Financial difficulties: Week 48
|
0 units on a scale
Standard Deviation 22.27
|
3.5 units on a scale
Standard Deviation 18.9
|
|
QLQ-C30 Individual Scale, Change Over Time: ITT Population
Financial difficulties: Week 56
|
-1.9 units on a scale
Standard Deviation 21.25
|
5.6 units on a scale
Standard Deviation 25.72
|
SECONDARY outcome
Timeframe: BaselinePopulation: 429 (ITT Population) 423 (ITT Population)
The QLQ-BR23 incorporates 5 multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning, and 3 single items to assess sexual enjoyment, upset by hair loss and future perspective. Most items were scaled one to four except the items contributing to the global health status/QoL, which were seven-point questions. Raw scores were transformed using a linear transformation to standardize the results so that scores ranged from 0-100. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.
Outcome measures
| Measure |
NKTR-102
n=429 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=423 Participants
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population
Body image
|
69.5 units on a scale
Standard Deviation 28.94
|
69.9 units on a scale
Standard Deviation 27.91
|
|
Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population
Sexual functioning
|
14.1 units on a scale
Standard Deviation 19.24
|
13.3 units on a scale
Standard Deviation 18.91
|
|
Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population
Systemic therapy side effects
|
21.9 units on a scale
Standard Deviation 16.37
|
22.3 units on a scale
Standard Deviation 15.15
|
|
Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population
Breast symptoms
|
15.3 units on a scale
Standard Deviation 21.55
|
15.8 units on a scale
Standard Deviation 20.79
|
|
Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population
Sexual enjoyment
|
36.1 units on a scale
Standard Deviation 29.25
|
34.2 units on a scale
Standard Deviation 30.77
|
|
Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population
Future perspective
|
38.7 units on a scale
Standard Deviation 30.53
|
36.1 units on a scale
Standard Deviation 29.0
|
|
Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population
Arm symptoms
|
20.8 units on a scale
Standard Deviation 23.4
|
22.2 units on a scale
Standard Deviation 22.75
|
|
Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population
Upset by hair loss
|
33.2 units on a scale
Standard Deviation 34.15
|
30.5 units on a scale
Standard Deviation 33.29
|
SECONDARY outcome
Timeframe: Up to 38 months.Population: 429 (ITT Population) 423 (ITT Population)
The QLQ-BR23 incorporates 5 multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning, and 3 single items assess sexual enjoyment, upset by hair loss and future perspective. Most items were scaled one to four except the items contributing to the global health status/QoL, which were seven-point questions. Raw scores were transformed using a linear transformation to standardize the results so that scores ranged from 0-100. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.
Outcome measures
| Measure |
NKTR-102
n=429 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=423 Participants
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
BR23 Score Change Over Time: ITT Population
Body image: Week 24
|
0.8 units on a scale
Standard Deviation 23.58
|
-4.7 units on a scale
Standard Deviation 20.97
|
|
BR23 Score Change Over Time: ITT Population
Body image: Week 48
|
-0.3 units on a scale
Standard Deviation 25.47
|
-1.1 units on a scale
Standard Deviation 28.93
|
|
BR23 Score Change Over Time: ITT Population
Body image: Week 56
|
3.9 units on a scale
Standard Deviation 25.53
|
-10.2 units on a scale
Standard Deviation 26.61
|
|
BR23 Score Change Over Time: ITT Population
Sexual functioning: Week 8
|
-0.8 units on a scale
Standard Deviation 16.07
|
-2.2 units on a scale
Standard Deviation 16.26
|
|
BR23 Score Change Over Time: ITT Population
Sexual functioning: Week 16
|
0.1 units on a scale
Standard Deviation 16.67
|
-0.8 units on a scale
Standard Deviation 17.28
|
|
BR23 Score Change Over Time: ITT Population
Sexual functioning: Week 24
|
-2.8 units on a scale
Standard Deviation 16.72
|
-1.4 units on a scale
Standard Deviation 15.7
|
|
BR23 Score Change Over Time: ITT Population
Sexual enjoyment: Week 8
|
2.6 units on a scale
Standard Deviation 19.84
|
-4.2 units on a scale
Standard Deviation 23.64
|
|
BR23 Score Change Over Time: ITT Population
Sexual enjoyment: Week 24
|
1.9 units on a scale
Standard Deviation 29.72
|
-3.5 units on a scale
Standard Deviation 28.1
|
|
BR23 Score Change Over Time: ITT Population
Sexual enjoyment: Week 32
|
2.0 units on a scale
Standard Deviation 23.48
|
-2.6 units on a scale
Standard Deviation 20.24
|
|
BR23 Score Change Over Time: ITT Population
Sexual enjoyment: Week 48
|
-27.8 units on a scale
Standard Deviation 25.09
|
6.7 units on a scale
Standard Deviation 14.91
|
|
BR23 Score Change Over Time: ITT Population
Future perspective: Week 8
|
3.5 units on a scale
Standard Deviation 28.3
|
1.5 units on a scale
Standard Deviation 27.21
|
|
BR23 Score Change Over Time: ITT Population
Future perspective: Week 40
|
7.1 units on a scale
Standard Deviation 28.05
|
13.3 units on a scale
Standard Deviation 37.75
|
|
BR23 Score Change Over Time: ITT Population
Future perspective: Week 56
|
16.0 units on a scale
Standard Deviation 28.25
|
-3.1 units on a scale
Standard Deviation 45.22
|
|
BR23 Score Change Over Time: ITT Population
Systemic therapy side effects: Week 8
|
2.3 units on a scale
Standard Deviation 13.74
|
7.9 units on a scale
Standard Deviation 16.03
|
|
BR23 Score Change Over Time: ITT Population
Systemic therapy side effects: Week 32
|
3.5 units on a scale
Standard Deviation 13.5
|
7.3 units on a scale
Standard Deviation 18.01
|
|
BR23 Score Change Over Time: ITT Population
Systemic therapy side effects: Week 48
|
0.3 units on a scale
Standard Deviation 11.74
|
6.4 units on a scale
Standard Deviation 15.68
|
|
BR23 Score Change Over Time: ITT Population
Breast symptoms: Week 8
|
-1.7 units on a scale
Standard Deviation 15.21
|
-0.2 units on a scale
Standard Deviation 13.82
|
|
BR23 Score Change Over Time: ITT Population
Breast symptoms: Week 32
|
-2.5 units on a scale
Standard Deviation 14.26
|
-2.8 units on a scale
Standard Deviation 13.63
|
|
BR23 Score Change Over Time: ITT Population
Arm symptoms: Week 16
|
-5.1 units on a scale
Standard Deviation 17.24
|
1.1 units on a scale
Standard Deviation 18.24
|
|
BR23 Score Change Over Time: ITT Population
Arm symptoms: Week 24
|
-4.9 units on a scale
Standard Deviation 20.06
|
-0.3 units on a scale
Standard Deviation 19.56
|
|
BR23 Score Change Over Time: ITT Population
Arm symptoms: Week 56
|
-5.6 units on a scale
Standard Deviation 19.44
|
-1.4 units on a scale
Standard Deviation 12.98
|
|
BR23 Score Change Over Time: ITT Population
Upset by hair loss: Week 8
|
-4.7 units on a scale
Standard Deviation 32.28
|
0.1 units on a scale
Standard Deviation 28.63
|
|
BR23 Score Change Over Time: ITT Population
Upset by hair loss: Week 24
|
6.8 units on a scale
Standard Deviation 35.02
|
3.5 units on a scale
Standard Deviation 30.3
|
|
BR23 Score Change Over Time: ITT Population
Upset by hair loss: Week 48
|
-16.7 units on a scale
Standard Deviation 31.91
|
21.7 units on a scale
Standard Deviation 36.89
|
|
BR23 Score Change Over Time: ITT Population
Body image: Week 8
|
-0.8 units on a scale
Standard Deviation 21.99
|
-2.2 units on a scale
Standard Deviation 20.49
|
|
BR23 Score Change Over Time: ITT Population
Body image: Week 16
|
-0.8 units on a scale
Standard Deviation 24.31
|
-2.3 units on a scale
Standard Deviation 20.91
|
|
BR23 Score Change Over Time: ITT Population
Body image: Week 32
|
-1.2 units on a scale
Standard Deviation 26.27
|
-0.3 units on a scale
Standard Deviation 22.23
|
|
BR23 Score Change Over Time: ITT Population
Body image: Week 40
|
3.3 units on a scale
Standard Deviation 22.63
|
-2.4 units on a scale
Standard Deviation 20.98
|
|
BR23 Score Change Over Time: ITT Population
Sexual functioning: Week 32
|
-2.2 units on a scale
Standard Deviation 19.12
|
-.7 units on a scale
Standard Deviation 12.82
|
|
BR23 Score Change Over Time: ITT Population
Sexual functioning: Week 40
|
-5.4 units on a scale
Standard Deviation 16.66
|
2.7 units on a scale
Standard Deviation 16.27
|
|
BR23 Score Change Over Time: ITT Population
Sexual functioning: Week 48
|
-9.6 units on a scale
Standard Deviation 19.68
|
1.6 units on a scale
Standard Deviation 15.88
|
|
BR23 Score Change Over Time: ITT Population
Sexual functioning: Week 56
|
-5.3 units on a scale
Standard Deviation 17.33
|
1.7 units on a scale
Standard Deviation 13.06
|
|
BR23 Score Change Over Time: ITT Population
Sexual enjoyment: Week 16
|
-0.3 units on a scale
Standard Deviation 18.41
|
-8.6 units on a scale
Standard Deviation 21.7
|
|
BR23 Score Change Over Time: ITT Population
Sexual enjoyment: Week 40
|
-15.3 units on a scale
Standard Deviation 29.69
|
7.1 units on a scale
Standard Deviation 13.11
|
|
BR23 Score Change Over Time: ITT Population
Sexual enjoyment: Week 56
|
-9.8 units on a scale
Standard Deviation 16.27
|
0 units on a scale
Standard Deviation 0
|
|
BR23 Score Change Over Time: ITT Population
Future perspective: Week 16
|
6.9 units on a scale
Standard Deviation 27.17
|
3.6 units on a scale
Standard Deviation 29.18
|
|
BR23 Score Change Over Time: ITT Population
Future perspective: Week 24
|
9.3 units on a scale
Standard Deviation 31.1
|
6.6 units on a scale
Standard Deviation 29.55
|
|
BR23 Score Change Over Time: ITT Population
Future perspective: Week 32
|
6.1 units on a scale
Standard Deviation 30.19
|
4.4 units on a scale
Standard Deviation 35.86
|
|
BR23 Score Change Over Time: ITT Population
Future perspective: Week 48
|
9.2 units on a scale
Standard Deviation 27.31
|
6.1 units on a scale
Standard Deviation 35.66
|
|
BR23 Score Change Over Time: ITT Population
Systemic therapy side effects: Week 16
|
3.0 units on a scale
Standard Deviation 14.95
|
9.1 units on a scale
Standard Deviation 17.7
|
|
BR23 Score Change Over Time: ITT Population
Systemic therapy side effects: Week 24
|
2.2 units on a scale
Standard Deviation 15.55
|
6.9 units on a scale
Standard Deviation 17.39
|
|
BR23 Score Change Over Time: ITT Population
Systemic therapy side effects: Week 40
|
3.2 units on a scale
Standard Deviation 16.62
|
10.1 units on a scale
Standard Deviation 18.33
|
|
BR23 Score Change Over Time: ITT Population
Systemic therapy side effects: Week 56
|
-1.1 units on a scale
Standard Deviation 11.06
|
6.8 units on a scale
Standard Deviation 21.84
|
|
BR23 Score Change Over Time: ITT Population
Breast symptoms: Week 16
|
-3.5 units on a scale
Standard Deviation 14.6
|
0.1 units on a scale
Standard Deviation 14.64
|
|
BR23 Score Change Over Time: ITT Population
Breast symptoms: Week 24
|
-4.8 units on a scale
Standard Deviation 10.52
|
-1.1 units on a scale
Standard Deviation 13.48
|
|
BR23 Score Change Over Time: ITT Population
Breast symptoms: Week 40
|
-1.9 units on a scale
Standard Deviation 14.59
|
-0.2 units on a scale
Standard Deviation 11.02
|
|
BR23 Score Change Over Time: ITT Population
Breast symptoms: Week 48
|
-2.7 units on a scale
Standard Deviation 12.16
|
0 units on a scale
Standard Deviation 13.79
|
|
BR23 Score Change Over Time: ITT Population
Breast symptoms: Week 56
|
-3.4 units on a scale
Standard Deviation 13.28
|
2.5 units on a scale
Standard Deviation 12.15
|
|
BR23 Score Change Over Time: ITT Population
Arm symptoms: Week 8
|
-3.0 units on a scale
Standard Deviation 16.72
|
-0.9 units on a scale
Standard Deviation 15.01
|
|
BR23 Score Change Over Time: ITT Population
Arm symptoms: Week 32
|
-4.4 units on a scale
Standard Deviation 18.39
|
-0.5 units on a scale
Standard Deviation 19.03
|
|
BR23 Score Change Over Time: ITT Population
Arm symptoms: Week 40
|
-6.0 units on a scale
Standard Deviation 21.86
|
5.2 units on a scale
Standard Deviation 18.39
|
|
BR23 Score Change Over Time: ITT Population
Arm symptoms: Week 48
|
-5.6 units on a scale
Standard Deviation 20.89
|
-1.4 units on a scale
Standard Deviation 12.98
|
|
BR23 Score Change Over Time: ITT Population
Upset by hair loss: Week 16
|
8.3 units on a scale
Standard Deviation 33.61
|
2.9 units on a scale
Standard Deviation 31.24
|
|
BR23 Score Change Over Time: ITT Population
Upset by hair loss: Week 32
|
6.9 units on a scale
Standard Deviation 31.76
|
-2.3 units on a scale
Standard Deviation 29.68
|
|
BR23 Score Change Over Time: ITT Population
Upset by hair loss: Week 40
|
-4.2 units on a scale
Standard Deviation 30.05
|
20.2 units on a scale
Standard Deviation 29.37
|
|
BR23 Score Change Over Time: ITT Population
Upset by hair loss: Week 56
|
-14.6 units on a scale
Standard Deviation 30.13
|
16.7 units on a scale
Standard Deviation 44.1
|
SECONDARY outcome
Timeframe: Up to 38 months.Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population pharmacokinetic (PK) model-derived mean AUC values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution.
Outcome measures
| Measure |
NKTR-102
n=95 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Population Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25]
NKTR-102
|
4619 μg·h/mL
Standard Deviation 4874
|
—
|
|
Population Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25]
Irinotecan
|
18.8 μg·h/mL
Standard Deviation 22.1
|
—
|
|
Population Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25]
SN38
|
5.32 μg·h/mL
Standard Deviation 6.74
|
—
|
|
Population Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25]
SN38G
|
40.6 μg·h/mL
Standard Deviation 39.2
|
—
|
|
Population Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25]
APC
|
4.0 μg·h/mL
Standard Deviation 5.1
|
—
|
SECONDARY outcome
Timeframe: Up to 38 months.Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population PK model-derived mean Cmax values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution.
Outcome measures
| Measure |
NKTR-102
n=95 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Population Mean ± SD Maximum Plasma Concentration (Cmax) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [26]
NKTR-102
|
62701 ng/mL
Standard Deviation 14576
|
—
|
|
Population Mean ± SD Maximum Plasma Concentration (Cmax) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [26]
Irinotecan
|
138 ng/mL
Standard Deviation 61.8
|
—
|
|
Population Mean ± SD Maximum Plasma Concentration (Cmax) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [26]
SN38
|
4.45 ng/mL
Standard Deviation 1.82
|
—
|
|
Population Mean ± SD Maximum Plasma Concentration (Cmax) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [26]
SN38G
|
47.7 ng/mL
Standard Deviation 43.1
|
—
|
|
Population Mean ± SD Maximum Plasma Concentration (Cmax) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [26]
APC
|
7.3 ng/mL
Standard Deviation 6.7
|
—
|
SECONDARY outcome
Timeframe: Up to 38 months.Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population PK model-derived mean t½ values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution. The t½ of all analytes was primarily driven by NKTR-102. Thus, the NKTR-102 t½ of 37 days also applies to all NKTR-102 metabolites.
Outcome measures
| Measure |
NKTR-102
n=95 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Population Mean ± SD Elimination Half-life (t½) for NKTR-102 After Multiple Administration of 145 mg/m^2 NKTR-102 [27]
|
36.8 days
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: Up to 38 months.ORR was defined as the proportion of subjects with a complete response (CR) or a partial response (PR), assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 The analyses were performed for subjects in the efficacy evaluable population who had measurable disease as determined by the investigator at baseline.
Outcome measures
| Measure |
NKTR-102
n=354 Participants
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=358 Participants
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Objective Response Rate (ORR): Efficacy Evaluable Population
|
16.4 percentage of subjects
Interval 12.7 to 20.7
|
17.0 percentage of subjects
Interval 13.3 to 21.3
|
Adverse Events
NKTR-102
Serious events: 128 serious events
Other events: 417 other events
Deaths: 323 deaths
Physician's Treatment of Choice
Serious events: 129 serious events
Other events: 404 other events
Deaths: 322 deaths
Serious adverse events
| Measure |
NKTR-102
n=425 participants at risk
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=406 participants at risk
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Vascular disorders
Aortic stenosis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Vascular disorders
Embolism
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Vascular disorders
Hypotension
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.4%
6/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
2.5%
10/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.99%
4/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Pyrexia
|
0.71%
3/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
1.2%
5/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
General physical health deterioration
|
0.71%
3/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.74%
3/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Asthenia
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.74%
3/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Chest pain
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Fatigue
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Multi-organ failure
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Non-cardiac chest pain
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Oedema peripheral
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Pain
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Generalised oedema
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Malaise
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Psychiatric disorders
Bipolar disorder
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Investigations
Blood bilirubin increased
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Investigations
Clostridium test positive
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Pericardial effusion
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Acute coronary syndrome
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Atrial fibrillation
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Cardiac failure
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Mitral valve incompetence
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Sinus arrest
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Sinus bradycardia
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Sinus tachycardia
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.5%
15/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
4.4%
18/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
1.7%
7/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
1.2%
5/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.94%
4/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
1.5%
6/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Blood and lymphatic system disorders
Anaemia
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Blood and lymphatic system disorders
Microangiopathic haemolytic anaemia
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Syncope
|
0.71%
3/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Brain oedema
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Headache
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.71%
3/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Cerebrovascular accident
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Cholinergic syndrome
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Convulsion
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Dizziness
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Dysgraphia
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Gliosis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Hydrocephalus
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Paraesthesia
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Spinal chord compression
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Eye disorders
Retinal detachment
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Ear and labyrinth disorders
Vertigo
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
17/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
10/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
1.5%
6/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Ascites
|
0.94%
4/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
1.2%
5/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Nausea
|
0.94%
4/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.74%
3/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Abdominal pain
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Colitis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Constipation
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Enterocolitis
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Enteritis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Ileitis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Ileus
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Oesophagitis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Hepatobiliary disorders
Hepatic failure
|
0.71%
3/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Hepatobiliary disorders
Cholangitis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Renal and urinary disorders
Renal failure acute
|
0.71%
3/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Renal and urinary disorders
Renal failure
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Endocrine disorders
Hypothyroidism
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
8/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
1.5%
6/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Pneumonia
|
0.94%
4/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.99%
4/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Urinary tract infection
|
0.94%
4/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.74%
3/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Bronchitis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.74%
3/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Cellulitis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.74%
3/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Device related infection
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Lower respiratory tract infection
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Lung infection
|
0.47%
2/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Sepsis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Escherichia sepsis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Gastroenteritis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Septic shock
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Urosepsis
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.49%
2/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Wound infection
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Abscess intestinal
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Acute haemorrhagic conjunctivitis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Breast infection
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Influenza
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Klebsiella infection
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Moraxella infection
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Oral herpes
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Pyelonephritis
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.25%
1/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Wound infection staphylococcal
|
0.24%
1/425 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
0.00%
0/406 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
Other adverse events
| Measure |
NKTR-102
n=425 participants at risk
NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|
Physician's Treatment of Choice
n=406 participants at risk
Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel
|
|---|---|---|
|
Investigations
Weight decreased
|
13.4%
57/425 • Number of events 65 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
5.9%
24/406 • Number of events 25 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Investigations
Neutrophil count decreased
|
6.1%
26/425 • Number of events 41 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
12.3%
50/406 • Number of events 126 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Investigations
Aspartate aminotransferase increased
|
5.4%
23/425 • Number of events 24 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
7.1%
29/406 • Number of events 31 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.6%
58/425 • Number of events 68 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
17.2%
70/406 • Number of events 87 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.9%
59/425 • Number of events 64 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
12.8%
52/406 • Number of events 55 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.6%
92/425 • Number of events 174 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
31.0%
126/406 • Number of events 244 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Blood and lymphatic system disorders
Anaemia
|
15.1%
64/425 • Number of events 83 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
20.2%
82/406 • Number of events 105 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Dizziness
|
12.9%
55/425 • Number of events 75 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
10.1%
41/406 • Number of events 51 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Dysgeusia
|
8.0%
34/425 • Number of events 41 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
6.9%
28/406 • Number of events 44 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Nervous system disorders
Neuropathy peripheral
|
2.1%
9/425 • Number of events 9 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
12.3%
50/406 • Number of events 62 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Eye disorders
Vision blurred
|
16.0%
68/425 • Number of events 161 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
3.0%
12/406 • Number of events 13 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Fatigue
|
34.1%
145/425 • Number of events 241 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
32.0%
130/406 • Number of events 163 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Asthenia
|
21.4%
91/425 • Number of events 142 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
28.1%
114/406 • Number of events 170 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Pyrexia
|
7.1%
30/425 • Number of events 39 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
15.5%
63/406 • Number of events 98 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
General disorders
Oedema peripheral
|
4.7%
20/425 • Number of events 22 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
10.3%
42/406 • Number of events 49 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Psychiatric disorders
Insomnia
|
6.8%
29/425 • Number of events 45 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
8.1%
33/406 • Number of events 35 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Psychiatric disorders
Anxiety
|
4.7%
20/425 • Number of events 26 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
5.4%
22/406 • Number of events 23 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Nausea
|
60.0%
255/425 • Number of events 478 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
38.2%
155/406 • Number of events 249 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Diarrhoea
|
65.2%
277/425 • Number of events 1202 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
19.5%
79/406 • Number of events 128 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Vomiting
|
40.5%
172/425 • Number of events 342 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
17.7%
72/406 • Number of events 109 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Constipation
|
26.4%
112/425 • Number of events 167 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
31.0%
126/406 • Number of events 152 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Abdominal pain
|
20.9%
89/425 • Number of events 147 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
11.6%
47/406 • Number of events 52 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.2%
56/425 • Number of events 71 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
9.1%
37/406 • Number of events 45 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
34/425 • Number of events 45 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
7.9%
32/406 • Number of events 50 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Gastrointestinal disorders
Stomatitis
|
4.0%
17/425 • Number of events 23 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
8.4%
34/406 • Number of events 43 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.4%
44/425 • Number of events 49 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
23.4%
95/406 • Number of events 102 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
23/425 • Number of events 28 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
5.9%
24/406 • Number of events 28 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
26/425 • Number of events 30 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
14.5%
59/406 • Number of events 89 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
39/425 • Number of events 45 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
9.6%
39/406 • Number of events 41 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
29/425 • Number of events 35 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
10.3%
42/406 • Number of events 55 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
27/425 • Number of events 32 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
8.6%
35/406 • Number of events 43 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.0%
17/425 • Number of events 20 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
8.6%
35/406 • Number of events 38 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
25/425 • Number of events 28 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
6.4%
26/406 • Number of events 29 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
25/425 • Number of events 28 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
6.4%
26/406 • Number of events 29 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.8%
16/425 • Number of events 16 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
6.4%
26/406 • Number of events 31 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.6%
130/425 • Number of events 169 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
24.1%
98/406 • Number of events 116 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.2%
39/425 • Number of events 54 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
9.1%
37/406 • Number of events 39 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
34/425 • Number of events 39 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
4.7%
19/406 • Number of events 25 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Urinary tract infection
|
6.1%
26/425 • Number of events 27 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
6.4%
26/406 • Number of events 28 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
15/425 • Number of events 18 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
6.7%
27/406 • Number of events 32 • Up to 38 months.
Safety Population NKTR-102 = 425; TPC = 406
|
Additional Information
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