Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer (NCT NCT00806156)
NCT ID: NCT00806156
Last Updated: 2021-07-12
Results Overview
The ORR was defined as the proportion of patients with a complete response (CR) or a partial response (PR) per RECIST 1.0 based upon the best response as assessed by the Investigator. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. The analysis was performed for patients in the Primary Efficacy Population.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
178 participants
Primary outcome timeframe
Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)
Results posted on
2021-07-12
Participant Flow
The study began with an initial Simon two-stage design in which patients were randomized 1:1 into one of two treatment schedules (145 mg/m2 q14d or q21d). During Stage 1, 20 patients were to be enrolled and treated in each schedule (q14d or q21d). If at least 1 response was observed in 20 evaluable patients within a treatment schedule, the treatment schedule would progress to Stage 2, where an additional 15 patients were to be enrolled for a total of 35 patients in the treatment schedule.
Participant milestones
| Measure |
NKTR-102 q14d
NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
|
NKTR-102 q21d
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
139
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
39
|
139
|
Reasons for withdrawal
| Measure |
NKTR-102 q14d
NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
|
NKTR-102 q21d
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
|
|---|---|---|
|
Overall Study
Death
|
35
|
95
|
|
Overall Study
Did not meet eligibility criteria
|
1
|
0
|
|
Overall Study
Study terminated by Sponsor
|
2
|
40
|
|
Overall Study
Consent withdrawn by subject
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer
Baseline characteristics by cohort
| Measure |
NKTR-102 q14d
n=39 Participants
NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
NKTR-102 q21d
n=139 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Total
n=178 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
|
27 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 12.14 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 11.49 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 11.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
The ORR was defined as the proportion of patients with a complete response (CR) or a partial response (PR) per RECIST 1.0 based upon the best response as assessed by the Investigator. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. The analysis was performed for patients in the Primary Efficacy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=104 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=104 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST): Primary Efficacy Population
|
14.4 Percentage of Patients
Interval 8.3 to 22.7
|
14.4 Percentage of Patients
Interval 8.3 to 22.7
|
—
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Best overall response was defined as the proportion of patients with a CR or a PR as assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and cancer antigen 125 (CA-125) criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the upper limit of normal (ULN) and within 2 weeks prior to starting treatment." Analysis was performed in MITT Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=37 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=132 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=169 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Best Overall Response by Gynecologic Cancer Intergroup (GCIG) Criteria: MITT Population
|
29.7 Percentage of Patients
Interval 15.9 to 47.0
|
25 Percentage of Patients
Interval 17.9 to 33.3
|
26 Percentage of Patients
Interval 19.6 to 33.3
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Primary Efficacy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=104 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=104 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Best Overall Response by GCIG Criteria: Primary Efficacy Population
|
25 Percentage of Patients
Interval 17.0 to 34.4
|
25 Percentage of Patients
Interval 17.0 to 34.4
|
—
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Platinum-Refractory Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=13 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=52 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=65 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Best Overall Response by GCIG Criteria: Platinum-Refractory Population
|
23.1 Percentage of Patients
Interval 5.0 to 53.8
|
17.3 Percentage of Patients
Interval 8.2 to 30.3
|
18.5 Percentage of Patients
Interval 9.9 to 30.0
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Prior PLD Therapy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=16 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=114 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=130 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Best Overall Response by GCIG Criteria: Prior PLD Therapy Population
|
25 Percentage of Patients
Interval 7.3 to 52.4
|
24.6 Percentage of Patients
Interval 17.0 to 33.5
|
24.6 Percentage of Patients
Interval 17.5 to 32.9
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
According to enhanced RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR an unambiguous increase in the sum of target lesion volumes with both 1) \>20% increase in the sum of volumes (SOV) of all target lesions (taking as reference the nadir) and 2) greater than two times the variability of the measurements estimated by the sponsor and/or its designees.
Outcome measures
| Measure |
NKTR-102 q21d
n=37 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=132 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=169 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Estimate of Progression-Free Survival (PFS): MITT Population
|
4.1 Months
Interval 2.6 to 6.7
|
4.4 Months
Interval 2.9 to 5.0
|
4.4 Months
Interval 3.1 to 5.3
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Primary Efficacy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=104 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=104 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Estimate of PFS: Primary Efficacy Population
|
4.4 Months
Interval 2.9 to 5.0
|
4.4 Months
Interval 2.9 to 5.0
|
—
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Platinum-Refractory Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=13 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=52 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=65 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Estimate of PFS: Platinum-Refractory Population
|
11.9 Months
Interval 2.0 to 15.0
|
2.7 Months
Interval 1.7 to 4.6
|
3 Months
Interval 2.0 to 5.3
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Prior PLD Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=16 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=114 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=130 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Estimate of PFS: Prior PLD Therapy Population
|
5.5 Months
Interval 2.2 to 11.4
|
4.4 Months
Interval 2.9 to 5.0
|
4.5 Months
Interval 3.1 to 5.3
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in MITT Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=37 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=132 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=169 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Analysis of Duration of Overall Response (DoR): MITT Population
|
4.1 Months
Interval 2.8 to 8.0
|
6.6 Months
Interval 3.6 to 10.9
|
5.7 Months
Interval 4.0 to 10.1
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Primary Efficacy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=104 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=104 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Analysis of DoR: Primary Efficacy Population
|
7.4 Months
Interval 3.6 to 13.2
|
7.4 Months
Interval 3.6 to 13.2
|
—
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Platinum-Refractory Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=13 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=52 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=65 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Analysis of DoR: Platinum-Refractory Population
|
10.8 Months
Interval 7.1 to 14.4
|
7.4 Months
Interval 2.9 to 12.6
|
7.4 Months
Interval 2.9 to 12.6
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Prior PLD Therapy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=16 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=114 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=130 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Analysis of DoR: Prior PLD Therapy Population
|
4.2 Months
Interval 4.1 to 14.4
|
7.4 Months
Interval 3.6 to 10.9
|
6.6 Months
Interval 4.0 to 10.9
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in MITT Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=32 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=109 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=141 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: CA-125 Response Rate: MITT Population
|
43.8 Percentage of Patients
Interval 26.4 to 62.3
|
34.9 Percentage of Patients
Interval 26.0 to 44.6
|
36.9 Percentage of Patients
Interval 28.9 to 45.4
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Primary Efficacy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=88 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=88 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: CA-125 Response Rate: Primary Efficacy Population
|
33 Percentage of Patients
Interval 23.3 to 43.8
|
33 Percentage of Patients
Interval 23.3 to 43.8
|
—
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Platinum-Refractory Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=11 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=40 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=51 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: CA-125 Response Rate: Platinum-Refractory Population
|
36.4 Percentage of Patients
Interval 10.9 to 69.2
|
20 Percentage of Patients
Interval 9.1 to 35.6
|
23.5 Percentage of Patients
Interval 12.8 to 37.5
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Prior PLD Therapy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=15 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=95 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=110 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: CA-125 Response Rate: Prior PLD Therapy Population
|
40 Percentage of Patients
Interval 16.3 to 67.7
|
33.7 Percentage of Patients
Interval 24.3 to 44.1
|
34.5 Percentage of Patients
Interval 25.7 to 44.2
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in MITT Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=37 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=132 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=169 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Clinical Benefit Rate: MITT Population
|
56.8 Percentage of Patients
Interval 39.5 to 72.9
|
50.8 Percentage of Patients
Interval 41.9 to 59.6
|
52.1 Percentage of Patients
Interval 44.3 to 59.8
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Primary Efficacy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=104 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=104 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Clinical Benefit Rate: Primary Efficacy Population
|
51 Percentage of Patients
Interval 41.0 to 60.9
|
51 Percentage of Patients
Interval 41.0 to 60.9
|
—
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Platinum-Refractory Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=13 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=52 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=65 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Clinical Benefit Rate: Platinum-Refractory Population
|
61.5 Percentage of Patients
Interval 31.6 to 86.1
|
38.5 Percentage of Patients
Interval 25.3 to 53.0
|
43.1 Percentage of Patients
Interval 30.8 to 56.0
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Prior PLD Therapy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=16 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=114 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=130 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Clinical Benefit Rate: Prior PLD Therapy Population
|
56.3 Percentage of Patients
Interval 29.9 to 80.2
|
50.9 Percentage of Patients
Interval 41.3 to 60.4
|
51.5 Percentage of Patients
Interval 42.6 to 60.4
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in MITT Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=37 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=132 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=169 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Analysis of Overall Survival (OS): MITT Population
|
11.1 Months
Interval 8.8 to 16.7
|
10.2 Months
Interval 8.2 to 12.2
|
10.6 Months
Interval 9.4 to 12.2
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Primary Efficacy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=104 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=104 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Analysis of OS: Primary Efficacy Population
|
10.9 Months
Interval 8.2 to 13.1
|
10.9 Months
Interval 8.2 to 13.1
|
—
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Platinum-Refractory Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=13 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=52 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=65 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Analysis of OS: Platinum-Refractory Population
|
11.1 Months
Interval 6.1 to 21.6
|
8 Months
Interval 5.0 to 12.2
|
9.4 Months
Interval 5.8 to 12.2
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Prior PLD Therapy Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=16 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=114 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=130 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: Kaplan-Meier Analysis of OS: Prior PLD Therapy Population
|
12.2 Months
Interval 8.8 to 16.7
|
11 Months
Interval 8.9 to 13.1
|
11 Months
Interval 9.5 to 12.5
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the MITT Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=37 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=132 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=169 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: ORR by RECIST: MITT Population
|
21.6 Percentage of Patients
Interval 9.8 to 38.2
|
15.2 Percentage of Patients
Interval 9.5 to 22.4
|
16.6 Percentage of Patients
Interval 11.3 to 23.0
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the PLD Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=16 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=114 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=130 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: ORR by RECIST: Prior PLD Population
|
18.8 Percentage of Patients
Interval 4.0 to 45.6
|
14.9 Percentage of Patients
Interval 8.9 to 22.8
|
15.4 Percentage of Patients
Interval 9.7 to 22.8
|
SECONDARY outcome
Timeframe: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)Population: Received at least one dose of study treatment
The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the Platinum-Refractory Population.
Outcome measures
| Measure |
NKTR-102 q21d
n=13 Participants
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
Primary Efficacy Population
n=52 Participants
The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.
|
MITT Population
n=65 Participants
The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.
|
|---|---|---|---|
|
Secondary: ORR by RECIST: Platinum-Refractory Population
|
15.4 Percentage of Patients
Interval 1.9 to 45.4
|
15.4 Percentage of Patients
Interval 6.9 to 28.1
|
15.4 Percentage of Patients
Interval 7.6 to 26.5
|
Adverse Events
NKTR-102 q14d
Serious events: 23 serious events
Other events: 38 other events
Deaths: 35 deaths
NKTR-102 q21d
Serious events: 78 serious events
Other events: 139 other events
Deaths: 95 deaths
Serious adverse events
| Measure |
NKTR-102 q14d
n=38 participants at risk
NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
NKTR-102 q21d
n=139 participants at risk
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Immune system disorders
Hypersensitivity
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
General disorders
Death
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
General disorders
Disease progression
|
5.3%
2/38 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
7.9%
11/139 • Number of events 11 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
General disorders
Fatigue
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
General disorders
General physical health deterioration
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
General disorders
Oedema peripheral
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
General disorders
Pyrexia
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
2.9%
4/139 • Number of events 4 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Investigations
Blood potassium decreased
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Investigations
Body temperature increased
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Investigations
Lipase increased
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Cardiac disorders
Angina pectoris
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Skin and subcutaneous tissue disorders
Pleural effusion
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.9%
3/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
2.9%
4/139 • Number of events 4 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
2.2%
3/139 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.3%
2/38 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
2.2%
3/139 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.3%
2/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia subjects affected /
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
1.4%
2/139 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Nervous system disorders
Cholinergic syndrome
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Nervous system disorders
Speech disorder
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
2/38 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.0%
7/139 • Number of events 8 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Ascites
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
1.4%
2/139 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.7%
9/38 • Number of events 10 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
15.1%
21/139 • Number of events 24 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
7.9%
3/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.0%
7/139 • Number of events 7 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
1.4%
2/139 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.0%
7/139 • Number of events 8 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
7.9%
11/139 • Number of events 19 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
3/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
6.5%
9/139 • Number of events 10 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Renal and urinary disorders
Renal failure
|
5.3%
2/38 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Hepatobiliary disorders
Cholestasis
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.4%
7/38 • Number of events 7 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
9.4%
13/139 • Number of events 15 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
2/38 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
1.4%
2/139 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Herpes oesophagitis
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Infection
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Lobar pneumonia
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
1.4%
2/139 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Respiratory tract infection
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Sepsis
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
1.4%
2/139 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.72%
1/139 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
0.00%
0/139 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
1.4%
2/139 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
Other adverse events
| Measure |
NKTR-102 q14d
n=38 participants at risk
NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
NKTR-102 q21d
n=139 participants at risk
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
|
|---|---|---|
|
Vascular disorders
Flushing
|
2.6%
1/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
6.5%
9/139 • Number of events 13 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Vascular disorders
Hypotension
|
7.9%
3/38 • Number of events 4 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
4.3%
6/139 • Number of events 6 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
General disorders
Asthenia
|
7.9%
3/38 • Number of events 5 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
8.6%
12/139 • Number of events 16 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
General disorders
Chills
|
5.3%
2/38 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.0%
7/139 • Number of events 11 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
General disorders
Fatigue
|
52.6%
20/38 • Number of events 38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
58.3%
81/139 • Number of events 198 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
General disorders
Oedema peripheral
|
18.4%
7/38 • Number of events 10 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
10.8%
15/139 • Number of events 20 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
General disorders
Pyrexia
|
28.9%
11/38 • Number of events 15 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
16.5%
23/139 • Number of events 33 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Psychiatric disorders
Anxiety
|
18.4%
7/38 • Number of events 8 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
8.6%
12/139 • Number of events 12 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Psychiatric disorders
Depression
|
7.9%
3/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
7.9%
11/139 • Number of events 13 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Psychiatric disorders
Insomnia
|
18.4%
7/38 • Number of events 8 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
10.8%
15/139 • Number of events 20 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Investigations
Blood creatinine increased
|
7.9%
3/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
7.2%
10/139 • Number of events 14 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Investigations
Haemoglobin decreased
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.8%
8/139 • Number of events 16 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Investigations
Weight decreased
|
47.4%
18/38 • Number of events 31 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
30.2%
42/139 • Number of events 51 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Cardiac disorders
Tachycardia
|
5.3%
2/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.0%
7/139 • Number of events 7 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Blood and lymphatic system disorders
Anaemia
|
26.3%
10/38 • Number of events 19 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
27.3%
38/139 • Number of events 65 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.9%
3/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
9.4%
13/139 • Number of events 43 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.7%
9/38 • Number of events 22 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
19.4%
27/139 • Number of events 74 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.6%
1/38 • Number of events 2 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.8%
8/139 • Number of events 14 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.4%
7/38 • Number of events 8 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
9.4%
13/139 • Number of events 14 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.8%
6/38 • Number of events 7 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
20.1%
28/139 • Number of events 39 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.9%
3/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
4.3%
6/139 • Number of events 7 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Nervous system disorders
Dizziness
|
28.9%
11/38 • Number of events 17 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
18.0%
25/139 • Number of events 36 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Nervous system disorders
Dysgeusia
|
21.1%
8/38 • Number of events 8 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
12.2%
17/139 • Number of events 24 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Nervous system disorders
Headache
|
15.8%
6/38 • Number of events 13 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
16.5%
23/139 • Number of events 42 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Nervous system disorders
Lethargy
|
5.3%
2/38 • Number of events 6 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.8%
8/139 • Number of events 13 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.5%
4/38 • Number of events 4 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
4.3%
6/139 • Number of events 8 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Eye disorders
Vision blurred
|
23.7%
9/38 • Number of events 14 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
18.7%
26/139 • Number of events 41 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Abdominal distension
|
18.4%
7/38 • Number of events 8 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
12.2%
17/139 • Number of events 19 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
42.1%
16/38 • Number of events 21 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
53.2%
74/139 • Number of events 128 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/38 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
7.2%
10/139 • Number of events 11 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.9%
3/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
10.8%
15/139 • Number of events 22 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Ascites
|
7.9%
3/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.8%
8/139 • Number of events 12 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Constipation
|
23.7%
9/38 • Number of events 12 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
36.7%
51/139 • Number of events 87 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
89.5%
34/38 • Number of events 230 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
74.1%
103/139 • Number of events 376 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Dry mouth
|
10.5%
4/38 • Number of events 4 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
3.6%
5/139 • Number of events 6 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Dyspepsia
|
21.1%
8/38 • Number of events 14 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
12.2%
17/139 • Number of events 30 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Flatulence
|
21.1%
8/38 • Number of events 10 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
11.5%
16/139 • Number of events 19 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Nausea
|
71.1%
27/38 • Number of events 70 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
77.0%
107/139 • Number of events 250 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Stomatitis
|
7.9%
3/38 • Number of events 8 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
12.2%
17/139 • Number of events 20 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Gastrointestinal disorders
Vomiting
|
60.5%
23/38 • Number of events 54 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
54.7%
76/139 • Number of events 176 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.6%
12/38 • Number of events 16 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
20.9%
29/139 • Number of events 35 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.9%
3/38 • Number of events 4 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
7.9%
11/139 • Number of events 12 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.4%
7/38 • Number of events 9 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
12.2%
17/139 • Number of events 23 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.2%
5/38 • Number of events 7 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.8%
8/139 • Number of events 11 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
4/38 • Number of events 6 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
10.8%
15/139 • Number of events 16 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
11.5%
16/139 • Number of events 25 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.6%
1/38 • Number of events 1 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
7.2%
10/139 • Number of events 16 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
4/38 • Number of events 5 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.8%
8/139 • Number of events 15 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.9%
3/38 • Number of events 3 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
7.9%
11/139 • Number of events 13 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
52.6%
20/38 • Number of events 35 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
49.6%
69/139 • Number of events 135 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
28.9%
11/38 • Number of events 20 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
15.8%
22/139 • Number of events 23 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.3%
2/38 • Number of events 5 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.0%
7/139 • Number of events 10 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
47.4%
18/38 • Number of events 24 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
20.1%
28/139 • Number of events 61 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.5%
4/38 • Number of events 4 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.8%
8/139 • Number of events 16 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.8%
6/38 • Number of events 6 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
10.8%
15/139 • Number of events 28 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Nasopharyngitis
|
13.2%
5/38 • Number of events 5 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
4.3%
6/139 • Number of events 7 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
3/38 • Number of events 5 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
5.0%
7/139 • Number of events 8 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
|
Infections and infestations
Urinary tract infection
|
15.8%
6/38 • Number of events 7 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
7.9%
11/139 • Number of events 22 • Throughout the duration of the study (approximately 3 years and 11 months).
Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \> 5% of patients.
|
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