Trial Outcomes & Findings for A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain (NCT NCT01619839)

NCT ID: NCT01619839

Last Updated: 2021-08-02

Results Overview

The first phase of this trial involved an open-label titration period where patients were given NKTR-181 at increasing doses up to a maximum of 400 mg twice daily until adequate pain control was achieved. Patients achieving adequate pain control were then progressed to the second phase of the trial where patients were randomized in a 1:1 ratio to receive either placebo or their tolerable dose level of NKTR-181. All efficacy data for NKTR-181 patients was combined into one group regardless of tolerable dose level. For this outcome, the subjects had to rate their worst pain intensity during the past 4 hours from 0 to 10 on an 11-point scale, where 0 represented one end of the continuum (i.e., no pain) and 10 represented the other extreme of pain intensity (i.e., worst pain imaginable).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

296 participants

Primary outcome timeframe

Baseline and Visit 10 (day 69)

Results posted on

2021-08-02

Participant Flow

A total of 296 subjects were enrolled in this study. Of these, one subject did not receive study drug in the open-label Titration Period because she had a history of drug abuse and thus did not meet entry criteria. Of the 295 subjects dosed during the open-label Titration Period, 213 subjects were randomized to treatment. All 295 subjects who received study drug were included in the safety analysis population.

Participant milestones

Participant milestones
Measure	100 mg NKTR-181 100 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. NKTR-181	200 mg NKTR-181 200 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. NKTR-181	300 mg NKTR-181 300 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days NKTR-181	400 mg NKTR-181 400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days NKTR-181	Placebo Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181. Placebo: Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181
Overall Study STARTED	48	31	18	10	106
Overall Study COMPLETED	43	27	17	9	97
Overall Study NOT COMPLETED	5	4	1	1	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	100 mg NKTR-181 n=48 Participants 100 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. NKTR-181	200 mg NKTR-181 n=31 Participants 200 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. NKTR-181	300 mg NKTR-181 n=18 Participants 300 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days NKTR-181	400 mg NKTR-181 n=10 Participants 400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days NKTR-181	Placebo n=106 Participants Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181. Placebo: Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181	Total n=213 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 9.77 • n=5 Participants	57.6 years STANDARD_DEVIATION 11.43 • n=7 Participants	60.6 years STANDARD_DEVIATION 9.57 • n=5 Participants	59.8 years STANDARD_DEVIATION 9.51 • n=4 Participants	60.1 years STANDARD_DEVIATION 9.55 • n=21 Participants	60.1 years STANDARD_DEVIATION 9.87 • n=8 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	18 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	66 Participants n=21 Participants	127 Participants n=8 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	3 Participants n=4 Participants	40 Participants n=21 Participants	86 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	21 Participants n=21 Participants	41 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	25 Participants n=7 Participants	14 Participants n=5 Participants	7 Participants n=4 Participants	83 Participants n=21 Participants	169 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	9 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	20 Participants n=21 Participants	40 Participants n=8 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	8 Participants n=4 Participants	82 Participants n=21 Participants	164 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Height	170.1 centimeters STANDARD_DEVIATION 10.84 • n=5 Participants	169.5 centimeters STANDARD_DEVIATION 11.55 • n=7 Participants	169.7 centimeters STANDARD_DEVIATION 9.41 • n=5 Participants	168.0 centimeters STANDARD_DEVIATION 11.37 • n=4 Participants	167.2 centimeters STANDARD_DEVIATION 10.40 • n=21 Participants	168.4 centimeters STANDARD_DEVIATION 10.62 • n=8 Participants
Weight	89.27 kilograms STANDARD_DEVIATION 17.496 • n=5 Participants	90.75 kilograms STANDARD_DEVIATION 22.355 • n=7 Participants	85.85 kilograms STANDARD_DEVIATION 16.739 • n=5 Participants	84.27 kilograms STANDARD_DEVIATION 18.918 • n=4 Participants	89.57 kilograms STANDARD_DEVIATION 19.116 • n=21 Participants	89.11 kilograms STANDARD_DEVIATION 18.967 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline and Visit 10 (day 69)

Outcome measures

Outcome measures
Measure	NKTR-181 n=106 Participants Patients who received at least one dose of NKTR-181	Placebo n=106 Participants Patients given placebo
The Mean Change From Baseline Pain Score to Pain Score at the End of the Double-blind Randomized Treatment Period.	-0.06 Change in Pain Score Standard Error 0.162	-0.01 Change in Pain Score Standard Error 0.168

SECONDARY outcome

Timeframe: Randomization Treatment period is 24 days

Outcome measures

Outcome measures
Measure	NKTR-181 n=106 Participants Patients who received at least one dose of NKTR-181	Placebo n=106 Participants Patients given placebo
Time to Discontinuation During the Double-blind Randomized Treatment Period for Any Reason	20.2 days Standard Deviation 4.21	20.2 days Standard Deviation 3.86

Adverse Events

100 mg NKTR-181

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

200 mg NKTR-181

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

300 mg NKTR-181

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

400 mg NKTR-181

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	100 mg NKTR-181 n=48 participants at risk；n=133 participants at risk 100 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. NKTR-181	200 mg NKTR-181 n=31 participants at risk；n=84 participants at risk 200 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. NKTR-181	300 mg NKTR-181 n=18 participants at risk；n=46 participants at risk 300 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days NKTR-181	400 mg NKTR-181 n=10 participants at risk；n=32 participants at risk 400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days NKTR-181	Placebo n=106 participants at risk Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181. Placebo: Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181
Cardiac disorders Atrial Fibrillation	0.00% 0/133 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	1.2% 1/84 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/46 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/32 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	— 0/0 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Cardiac disorders Coronary Artery Stenosis	0.00% 0/133 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/84 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/46 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	3.1% 1/32 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	— 0/0 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.

Other adverse events

Other adverse events
Measure	100 mg NKTR-181 n=48 participants at risk；n=133 participants at risk 100 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. NKTR-181	200 mg NKTR-181 n=31 participants at risk；n=84 participants at risk 200 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. NKTR-181	300 mg NKTR-181 n=18 participants at risk；n=46 participants at risk 300 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days NKTR-181	400 mg NKTR-181 n=10 participants at risk；n=32 participants at risk 400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days NKTR-181	Placebo n=106 participants at risk Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181. Placebo: Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181
Infections and infestations Gingival Infection	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Infections and infestations Nasopharyngitis	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	1.9% 2/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Injury, poisoning and procedural complications Contusion	2.1% 1/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	10.0% 1/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	1.9% 2/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Nervous system disorders Somnolence	4.2% 2/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	12.9% 4/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	10.0% 1/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	4.7% 5/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Nervous system disorders Dizziness	4.2% 2/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	6.5% 2/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	11.1% 2/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	1.9% 2/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	10.0% 1/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.94% 1/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Ear and labyrinth disorders Ear Pain	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	10.0% 1/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.94% 1/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Eye disorders Lacrimation Increased	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	11.1% 2/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Gastrointestinal disorders Constipation	18.8% 9/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	25.8% 8/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	27.8% 5/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	20.0% 2/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	14.2% 15/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Gastrointestinal disorders Nausea	8.3% 4/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	12.9% 4/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	16.7% 3/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	6.6% 7/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Gastrointestinal disorders Dry Mouth	4.2% 2/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	6.5% 2/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	2.8% 3/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Gastrointestinal disorders Vomiting	2.1% 1/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	12.9% 4/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	2.8% 3/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Gastrointestinal disorders Abdominal Pain Upper	2.1% 1/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	3.2% 1/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	6.5% 2/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	4.7% 5/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
General disorders Fatigue	2.1% 1/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	1.9% 2/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Infections and infestations Gastroenteritis	2.1% 1/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Infections and infestations Upper Respiratory Tract Infection	2.1% 1/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	3.8% 4/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Skin and subcutaneous tissue disorders Pruritus	2.1% 1/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	3.2% 1/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	10.0% 1/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	1.9% 2/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Nervous system disorders Headache	4.2% 2/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	9.7% 3/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	3.8% 4/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Nervous system disorders Tremor	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.94% 1/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Injury, poisoning and procedural complications Heat Exhaustion	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	5.6% 1/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Infections and infestations Gastroenteritis Viral	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	10.0% 1/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.94% 1/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.
Infections and infestations Viral Infection	0.00% 0/48 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/31 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.00% 0/18 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	10.0% 1/10 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.	0.94% 1/106 Please note that the number of participants at risk analyzed for Serious Adverse Events includes all patients that were enrolled in the study not just the ones that were randomized to treatment.

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