Trial Outcomes & Findings for A Phase 1/2 Multicenter Dose Escalation and Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumors (NCT NCT02869295)

NCT ID: NCT02869295

Last Updated: 2021-07-29

Results Overview

This outcome quantifies the number and types of adverse events associated with NKTR-214.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

28 participants

Primary outcome timeframe

30 days after last dose, approximately 533 days

Results posted on

2021-07-29

Participant Flow

The Sponsor discontinued enrollment in order to allow the clinical development program for NKTR-214 to continue with other studies in which NKTR-214 was administered in combination with checkpoint inhibitors, based on biomarker analysis, which showed infiltration of immune cells within tumor tissue.

Participant milestones

Participant milestones
Measure	NKTR-214 0.003 mg/kg q21d This group will be given NKTR-214 at a dose of 0.003 mg/kg every 21 days	NKTR-214 0.006 mg/kg q21d This group will be given NKTR-214 at a dose of 0.006 mg/kg every 21 days	NKTR-214 0.006 mg/kg q14d This group will be given NKTR-214 at a dose of 0.006 mg/kg every 14 days	NKTR-214 0.009 mg/kg q21d This group will be given NKTR-214 at a dose of 0.009 mg/kg every 21 days	NKTR-214 0.012 mg/kg q21d This group will be given NKTR-214 at a dose of 0.012 mg/kg every 21 days
Overall Study STARTED	4	11	6	6	1
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	4	11	6	6	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 1/2 Multicenter Dose Escalation and Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NKTR-214 0.003 mg/kg q21d n=4 Participants NKTR-214 given at a dose of 0.003 mg/kg every 21 days	NKTR-214 0.006 mg/kg q21d n=11 Participants NKTR-214 given at a dose of 0.006 mg/kg every 21 days	NKTR-214 0.006 mg/kg q14d n=6 Participants NKTR-214 given at a dose of 0.006 mg/kg every 14 days	NKTR-214 0.009 mg/kg q21d n=6 Participants NKTR-214 given at a dose of 0.009 mg/kg every 21 days	NKTR-214 0.012 mg/kg q21d n=1 Participants NKTR-214 given at a dose of 0.012 mg/kg every 21 days	Total n=28 Participants Total of all reporting groups
Age, Continuous	54.8 years STANDARD_DEVIATION 14.17 • n=39 Participants	56.5 years STANDARD_DEVIATION 11.59 • n=41 Participants	62.0 years STANDARD_DEVIATION 10.16 • n=35 Participants	60.8 years STANDARD_DEVIATION 5.00 • n=31 Participants	43.0 years STANDARD_DEVIATION NA • n=146 Participants	57.9 years STANDARD_DEVIATION 10.58 • n=19 Participants
Sex: Female, Male Female	1 Participants n=39 Participants	6 Participants n=41 Participants	2 Participants n=35 Participants	2 Participants n=31 Participants	0 Participants n=146 Participants	11 Participants n=19 Participants
Sex: Female, Male Male	3 Participants n=39 Participants	5 Participants n=41 Participants	4 Participants n=35 Participants	4 Participants n=31 Participants	1 Participants n=146 Participants	17 Participants n=19 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	1 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	1 Participants n=19 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants	2 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	2 Participants n=19 Participants
Race (NIH/OMB) White	4 Participants n=39 Participants	8 Participants n=41 Participants	6 Participants n=35 Participants	6 Participants n=31 Participants	1 Participants n=146 Participants	25 Participants n=19 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status, n(%) 0	3 Participants n=39 Participants	7 Participants n=41 Participants	2 Participants n=35 Participants	3 Participants n=31 Participants	1 Participants n=146 Participants	16 Participants n=19 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status, n(%) 1	1 Participants n=39 Participants	4 Participants n=41 Participants	4 Participants n=35 Participants	3 Participants n=31 Participants	0 Participants n=146 Participants	12 Participants n=19 Participants
Status Enrollment Metastatic	4 Participants n=39 Participants	9 Participants n=41 Participants	6 Participants n=35 Participants	6 Participants n=31 Participants	1 Participants n=146 Participants	26 Participants n=19 Participants
Status Enrollment Locally Recurrent	0 Participants n=39 Participants	2 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	2 Participants n=19 Participants
Lines of Prior Systemic Cancer Therapy	5.3 number of lines of therapy STANDARD_DEVIATION 4.72 • n=39 Participants	1.8 number of lines of therapy STANDARD_DEVIATION 1.25 • n=41 Participants	3.0 number of lines of therapy STANDARD_DEVIATION 2.53 • n=35 Participants	3.3 number of lines of therapy STANDARD_DEVIATION 2.34 • n=31 Participants	1 number of lines of therapy STANDARD_DEVIATION NA • n=146 Participants	2.9 number of lines of therapy STANDARD_DEVIATION 2.59 • n=19 Participants
Prior Therapies # of Participants with previous Chemotherapy	3 participants n=39 Participants	2 participants n=41 Participants	4 participants n=35 Participants	1 participants n=31 Participants	0 participants n=146 Participants	10 participants n=19 Participants
Prior Therapies # of Participants with previous Targeted Therapy	3 participants n=39 Participants	8 participants n=41 Participants	2 participants n=35 Participants	3 participants n=31 Participants	0 participants n=146 Participants	14 participants n=19 Participants
Prior Therapies # of Participants with previous Immune Checkpoint Inhibitor (ICI) Only	3 participants n=39 Participants	4 participants n=41 Participants	2 participants n=35 Participants	6 participants n=31 Participants	1 participants n=146 Participants	16 participants n=19 Participants
Prior Therapies # of Participants with previous ICI and other immunotherapy	1 participants n=39 Participants	1 participants n=41 Participants	0 participants n=35 Participants	4 participants n=31 Participants	0 participants n=146 Participants	6 participants n=19 Participants

PRIMARY outcome

Timeframe: 30 days after last dose, approximately 533 days

This outcome quantifies the number and types of adverse events associated with NKTR-214.

Outcome measures

Outcome measures
Measure	NKTR-214 0.003 mg/kg q21d n=4 Participants NKTR-214 given at a dose of 0.003 mg/kg every 21 days	NKTR-214 0.006 mg/kg q21d n=11 Participants NKTR-214 given at a dose of 0.006 mg/kg every 21 days	NKTR-214 0.006 mg/kg q14d n=6 Participants NKTR-214 given at a dose of 0.006 mg/kg every 14 days	NKTR-214 0.009 mg/kg q21d n=6 Participants NKTR-214 given at a dose of 0.009 mg/kg every 21 days	NKTR-214 0.012 mg/kg q21d n=1 Participants NKTR-214 given at a dose of 0.012 mg/kg every 21 days
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Anemia Grade 1-2	2 events	1 events	0 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Anemia Grade 3-5	0 events	1 events	0 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Hypotension Grade 1-2	2 events	8 events	2 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Syncope Grade 3-5	0 events	1 events	1 events	0 events	1 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Headache Grade 1-2	3 events	2 events	1 events	2 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Headache Grade 3-5	0 events	1 events	0 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Metastases to Central Nervous System Grade 3-5	0 events	2 events	0 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Constipation Grade 1-2	2 events	3 events	2 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Constipation Grade 3-5	1 events	0 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Peripheral Edema Grade 1-2	0 events	4 events	1 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Peripheral Edema Grade 3-5	0 events	1 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Abdominal Pain Grade 1-2	1 events	1 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Abdominal pain Grade 3-5	0 events	0 events	2 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Pleural Effusion Grade 1-2	1 events	2 events	0 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Pleural Effusion Grade 3-5	1 events	0 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Confusional State Grade 1-2	0 events	0 events	2 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Confusional State Grade 3-5	0 events	1 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Infusion Related Reaction Grade 1-2	0 events	1 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Infusion Related Reaction Grade 3-5	0 events	0 events	0 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Presyncope Grade 1-2	0 events	1 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Presyncope Grade 3-5	0 events	1 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Brain Edema Grade 3-5	0 events	1 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Disease Progression Grade 3-5	0 events	0 events	1 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Gastroduodenal Hemorrhage Grade 3-5	0 events	1 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Hemiparesis Grade 3-5	0 events	1 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Hypovolemic Shock Grade 3-5	0 events	0 events	0 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Lipase Increased Grade 3-5	1 events	0 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Liver Function Test Abnormal Grade 3-5	0 events	0 events	0 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Lower Gastrointestinal Hemorrhage Grade 3-5	0 events	0 events	1 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Metastases to Meninges Grade 3-5	0 events	1 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Sepsis Grade 3-5	0 events	0 events	1 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Fatigue Grade 1-2	3 events	9 events	5 events	5 events	1 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Flu-Like Symptoms Grade 1-2	3 events	8 events	4 events	5 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Pruritus Grade 1-2	2 events	7 events	5 events	4 events	1 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Decreased Appetite Grade 1-2	1 events	6 events	4 events	4 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Rash Grade 1-2	3 events	6 events	4 events	2 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Arthralgia Grade 1-2	1 events	3 events	5 events	2 events	1 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Cough Grade 1-2	1 events	5 events	2 events	3 events	1 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Nausea Grade 1-2	3 events	3 events	3 events	2 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Diarrhea Grade 1-2	3 events	2 events	1 events	3 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Dyspnea Grade 1-2	3 events	4 events	1 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Nasal Congestion Grade 1-2	1 events	2 events	2 events	3 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Dizziness Grade 1-2	2 events	3 events	1 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Myalgia Grade 1-2	0 events	3 events	1 events	2 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Vomiting Grade 1-2	1 events	2 events	2 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Weight Decreased Grade 1-2	2 events	1 events	0 events	2 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Flushing Grade 1-2	0 events	1 events	2 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Event of Anxiety Grade 1-2	1 events	1 events	0 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Blood creatine increased Grade 1-2	0 events	1 events	1 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Cytokine Release Syndrome Grade 1-2	0 events	0 events	0 events	2 events	1 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Dry Skin Grade 1-2	1 events	2 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Dyspepsia Grade 1-2	0 events	0 events	1 events	1 events	1 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Generalized edema Grade 1-2	0 events	1 events	1 events	0 events	1 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Muscular Weakness Grade 1-2	1 events	1 events	1 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Oropharyngeal Pain Grade 1-2	1 events	2 events	0 events	0 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Pain Extremity Grade 1-2	0 events	1 events	1 events	1 events	0 events
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) # of Events of Hypotension Grade 3-5	0 events	1 events	2 events	1 events	1 events

PRIMARY outcome

Timeframe: 30 days after last dose, up to 533 days

The data below reflects the incidence of Dose Limiting Toxicity Events observed in this trial.

Outcome measures

Outcome measures
Measure	NKTR-214 0.003 mg/kg q21d n=4 Participants NKTR-214 given at a dose of 0.003 mg/kg every 21 days	NKTR-214 0.006 mg/kg q21d n=11 Participants NKTR-214 given at a dose of 0.006 mg/kg every 21 days	NKTR-214 0.006 mg/kg q14d n=6 Participants NKTR-214 given at a dose of 0.006 mg/kg every 14 days	NKTR-214 0.009 mg/kg q21d n=6 Participants NKTR-214 given at a dose of 0.009 mg/kg every 21 days	NKTR-214 0.012 mg/kg q21d n=1 Participants NKTR-214 given at a dose of 0.012 mg/kg every 21 days
Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) # of Events of Grade 3 Syncope	0 events	0 events	0 events	0 events	1 events
Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) # of Events of Grade 3 Hypotension	0 events	0 events	0 events	0 events	1 events

Adverse Events

NKTR-214 0.003 mg/kg q21d

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

NKTR-214 0.006 mg/kg q21d

Serious events: 5 serious events

Other events: 11 other events

Deaths: 3 deaths

NKTR-214 0.006 mg/kg q14d

Serious events: 4 serious events

Other events: 6 other events

Deaths: 2 deaths

NKTR-214 0.009 mg/kg q21d

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

NKTR-214 0.012 mg/kg q21d

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NKTR-214 0.003 mg/kg q21d n=4 participants at risk NKTR-214 given at a dose of 0.003 mg/kg every 21 days	NKTR-214 0.006 mg/kg q21d n=11 participants at risk NKTR-214 given at a dose of 0.006 mg/kg every 21 days	NKTR-214 0.006 mg/kg q14d n=6 participants at risk NKTR-214 given at a dose of 0.006 mg/kg every 14 days	NKTR-214 0.009 mg/kg q21d n=6 participants at risk NKTR-214 given at a dose of 0.009 mg/kg every 21 days	NKTR-214 0.012 mg/kg q21d n=1 participants at risk NKTR-214 given at a dose of 0.012 mg/kg every 21 days
Cardiac disorders Syncope	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Anemia	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Atrial Fibrillation	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Nervous system disorders Metastases to Central Nervous System	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	18.2% 2/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Constipation	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Abdominal Pain	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Hepatobiliary disorders Ascites	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	50.0% 2/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Disease Progression	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Gastroduodenal Hemorrhage	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Metabolism and nutrition disorders Lipase Increased	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Hepatobiliary disorders Liver Function Test Abnormal	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Infections and infestations Sepsis	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Hypotension	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	18.2% 2/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Infections and infestations Cytokine Release Syndrome	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Hypersensitivity	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Musculoskeletal and connective tissue disorders Humerus Fracture	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.

Other adverse events

Other adverse events
Measure	NKTR-214 0.003 mg/kg q21d n=4 participants at risk NKTR-214 given at a dose of 0.003 mg/kg every 21 days	NKTR-214 0.006 mg/kg q21d n=11 participants at risk NKTR-214 given at a dose of 0.006 mg/kg every 21 days	NKTR-214 0.006 mg/kg q14d n=6 participants at risk NKTR-214 given at a dose of 0.006 mg/kg every 14 days	NKTR-214 0.009 mg/kg q21d n=6 participants at risk NKTR-214 given at a dose of 0.009 mg/kg every 21 days	NKTR-214 0.012 mg/kg q21d n=1 participants at risk NKTR-214 given at a dose of 0.012 mg/kg every 21 days
Cardiac disorders Hypotension Grade 1-2	50.0% 2/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	72.7% 8/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Nervous system disorders Headache Grade 1-2	75.0% 3/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	18.2% 2/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Anemia Grade 1-2	50.0% 2/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Constipation Grade 1-2	50.0% 2/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	27.3% 3/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Peripheral Edema Grade 1-2	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	36.4% 4/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Abdominal Pain Grade 1-2	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Respiratory, thoracic and mediastinal disorders Pleural Effusion Grade 1-2	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	18.2% 2/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Nervous system disorders Confusional State Grade 1-2	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Injury, poisoning and procedural complications Infusion Related Reaction Grade 1-2	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Presyncope Grade 1-2	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Fatigue Grade 1-2	75.0% 3/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	81.8% 9/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	83.3% 5/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	83.3% 5/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Fatigue Grade 1-2	75.0% 3/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	81.8% 9/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	83.3% 5/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	83.3% 5/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Infections and infestations Flu-Like Symptoms Grade 1-2	75.0% 3/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	72.7% 8/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	66.7% 4/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	83.3% 5/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Skin and subcutaneous tissue disorders Pruritus Grade 1-2	50.0% 2/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	63.6% 7/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	83.3% 5/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	66.7% 4/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Decreased Appetite Grade 1-2	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	54.5% 6/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	66.7% 4/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	66.7% 4/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Skin and subcutaneous tissue disorders Rash Grade 1-2	75.0% 3/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	54.5% 6/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	66.7% 4/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Arthralgia Grade 1-2	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	27.3% 3/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	83.3% 5/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Cough Grade 1-2	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	45.5% 5/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	50.0% 3/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Nausea Grade 1-2	75.0% 3/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	27.3% 3/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	50.0% 3/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Diarrhea Grade 1-2	75.0% 3/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	18.2% 2/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	50.0% 3/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Respiratory, thoracic and mediastinal disorders Dyspnea Grade 1-2	75.0% 3/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	36.4% 4/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Respiratory, thoracic and mediastinal disorders Nasal Congestion Grade 1-2	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	18.2% 2/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	50.0% 3/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Dizziness Grade 1-2	50.0% 2/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	27.3% 3/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Myalgia Grade 1-2	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	27.3% 3/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Vomiting Grade 1-2	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	18.2% 2/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Weight Decreased Grade 1-2	50.0% 2/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Flushing Grade 1-2	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Nervous system disorders Anxiety Grade 1-2	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Metabolism and nutrition disorders Blood creatine increased Grade 1-2	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Infections and infestations Cytokine Release Syndrome Grade 1-2	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Skin and subcutaneous tissue disorders Dry Skin Grade 1-2	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	18.2% 2/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Dyspepsia Grade 1-2	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Generalized Edema Grade 1-2	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Musculoskeletal and connective tissue disorders Muscular Weakness Grade 1-2	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Oropharyngeal Pain	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	18.2% 2/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Pain Extremity Grade 1-2	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Syncope Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Headache Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Anemia Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Nervous system disorders Metastases to Central Nervous System Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	18.2% 2/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Constipation Grade 3-5	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Peripheral Edema Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Abdominal Pain Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Respiratory, thoracic and mediastinal disorders Pleural Effusion Grade 3-5	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Nervous system disorders Confusional State Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Injury, poisoning and procedural complications Infusion Related Reaction Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Presyncope Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Nervous system disorders Brain Edema Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Disease Progression Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Gastroduodenal Hemorrhage Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Hemiparesis Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Metabolism and nutrition disorders Hypovolemic Shock Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Metabolism and nutrition disorders Lipase Increased Grade 3-5	25.0% 1/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Metabolism and nutrition disorders Liver Function Test Abnormal Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
General disorders Metastases to Meninges Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Infections and infestations Sepsis Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	0.00% 0/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Cardiac disorders Hypotension Grade 3-5	0.00% 0/4 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	9.1% 1/11 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	33.3% 2/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	16.7% 1/6 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.	100.0% 1/1 • Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.

Additional Information

Study Director

Nektar Therapeutics

Phone: 415-482-5300

Email: [email protected]

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