Trial Outcomes & Findings for NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b) (NCT NCT00598975)
NCT ID: NCT00598975
Last Updated: 2021-07-12
Results Overview
Number of patients with Dose Limiting Toxicities
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
12 months
Results posted on
2021-07-12
Participant Flow
Participant milestones
| Measure |
NKTR-102 100 mg/m2 + Cetuximab
NKTR-102 100 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
NKTR-102 125 mg/m2 + Cetuximab
NKTR-102 125 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
|
Overall Study
Completed Cycle 1
|
12
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
| Measure |
NKTR-102 100 mg/m2 + Cetuximab
NKTR-102 100 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
NKTR-102 125 mg/m2 + Cetuximab
NKTR-102 125 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Brain metastases
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Withdrawal of consent
|
0
|
1
|
|
Overall Study
Disease progression
|
8
|
3
|
|
Overall Study
Tx delayed >2 wks, hospitalized for AE
|
1
|
0
|
Baseline Characteristics
NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b)
Baseline characteristics by cohort
| Measure |
NKTR-102 100 mg/m2 + Cetuximab
n=12 Participants
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
NKTR-102 125 mg/m2 + Cetuximab
n=6 Participants
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 years
n=93 Participants
|
65.5 years
n=4 Participants
|
64.0 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Copies of UGT1A1*28
Not detected
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Copies of UGT1A1*28
One Copy (Heterozygous)
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Copies of UGT1A1*28
Two Copies (Homozygous)
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
ECOG Performance
0
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
ECOG Performance
1
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
ECOG Performance
2
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: ITT/Safety Population
Number of patients with Dose Limiting Toxicities
Outcome measures
| Measure |
NKTR-102 100 mg/m2 + Cetuximab
n=12 Participants
NKTR-102 100 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
NKTR-102 125 mg/m2 + Cetuximab
n=6 Participants
NKTR-102 125 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
Total
n=18 Participants
NKTR-102 Overall Total
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
|---|---|---|---|
|
Number of Patients With Dose Limiting Toxicities
Dehydration
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Dose Limiting Toxicities
Diarrhoea
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Dose Limiting Toxicities
Renal Failure Acute
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT/Safety Population
Number of patients with Dose Limiting Toxicities by NCI-CTCAE
Outcome measures
| Measure |
NKTR-102 100 mg/m2 + Cetuximab
n=12 Participants
NKTR-102 100 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
NKTR-102 125 mg/m2 + Cetuximab
n=6 Participants
NKTR-102 125 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
Total
n=18 Participants
NKTR-102 Overall Total
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
|---|---|---|---|
|
Number of Patients With Dose Limiting Toxicities by NCI-CTCAE
Renal Failure Acute : Grade 4
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Dose Limiting Toxicities by NCI-CTCAE
Dehydration : Any grade
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Dose Limiting Toxicities by NCI-CTCAE
Dehydration : Grade 3
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Dose Limiting Toxicities by NCI-CTCAE
Diarrhoea : Any grade
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Dose Limiting Toxicities by NCI-CTCAE
Diarrhoea : Grade 3
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Dose Limiting Toxicities by NCI-CTCAE
Renal Failure Acute : Any grade
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT/Safety Population
Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The best overall response was the best response recorded from the start of the study drug until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Outcome measures
| Measure |
NKTR-102 100 mg/m2 + Cetuximab
n=12 Participants
NKTR-102 100 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
NKTR-102 125 mg/m2 + Cetuximab
n=6 Participants
NKTR-102 125 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
Total
n=18 Participants
NKTR-102 Overall Total
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
|---|---|---|---|
|
Number of Patients With Overall Response
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Overall Response
Partial Response
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Overall Response
Stable Disease
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Patients With Overall Response
Progressive Disease
|
7 Participants
|
1 Participants
|
8 Participants
|
Adverse Events
NKTR-102 100 mg/m2 + Cetuximab
Serious events: 5 serious events
Other events: 12 other events
Deaths: 1 deaths
NKTR-102 125 mg/m2 + Cetuximab
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Total
Serious events: 8 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
NKTR-102 100 mg/m2 + Cetuximab
n=12 participants at risk
NKTR-102 100 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
NKTR-102 125 mg/m2 + Cetuximab
n=6 participants at risk
NKTR-102 125 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
Total
n=18 participants at risk
NKTR-102 Overall Tota
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.l
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • 12 months
|
16.7%
1/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
General disorders
Fatigue
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
General disorders
Pyrexia
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Renal and urinary disorders
Renal acute failure
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Vascular disorders
Deep vein thrombosis
|
8.3%
1/12 • 12 months
|
16.7%
1/6 • 12 months
|
11.1%
2/18 • 12 months
|
Other adverse events
| Measure |
NKTR-102 100 mg/m2 + Cetuximab
n=12 participants at risk
NKTR-102 100 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
NKTR-102 125 mg/m2 + Cetuximab
n=6 participants at risk
NKTR-102 125 mg/m2 + Cetuximab Arm
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
|
Total
n=18 participants at risk
NKTR-102 Overall Tota
All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.l
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
75.0%
9/12 • 12 months
|
100.0%
6/6 • 12 months
|
83.3%
15/18 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
9/12 • 12 months
|
83.3%
5/6 • 12 months
|
77.8%
14/18 • 12 months
|
|
General disorders
Fatigue
|
75.0%
9/12 • 12 months
|
50.0%
3/6 • 12 months
|
66.7%
12/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
66.7%
8/12 • 12 months
|
50.0%
3/6 • 12 months
|
61.1%
11/18 • 12 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
66.7%
8/12 • 12 months
|
50.0%
3/6 • 12 months
|
61.1%
11/18 • 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
2/12 • 12 months
|
33.3%
2/6 • 12 months
|
22.2%
4/18 • 12 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Eye disorders
Vision blurred
|
16.7%
2/12 • 12 months
|
0.00%
0/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Eye disorders
Vitreous floaters
|
16.7%
2/12 • 12 months
|
0.00%
0/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
5/12 • 12 months
|
83.3%
5/6 • 12 months
|
55.6%
10/18 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
41.7%
5/12 • 12 months
|
50.0%
3/6 • 12 months
|
44.4%
8/18 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • 12 months
|
0.00%
0/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
2/12 • 12 months
|
0.00%
0/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Gastrointestinal disorders
Oral pain
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Gastrointestinal disorders
Pancreatic insufficiency
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
General disorders
Pyrexia
|
41.7%
5/12 • 12 months
|
16.7%
1/6 • 12 months
|
33.3%
6/18 • 12 months
|
|
General disorders
Chills
|
25.0%
3/12 • 12 months
|
33.3%
2/6 • 12 months
|
27.8%
5/18 • 12 months
|
|
General disorders
Asthenia
|
8.3%
1/12 • 12 months
|
33.3%
2/6 • 12 months
|
16.7%
3/18 • 12 months
|
|
General disorders
Adverse drug reaction
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
General disorders
Facial pain
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
General disorders
Mucosal inflammation
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Infections and infestations
Cellulitis
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Infections and infestations
Hordeolum
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Infections and infestations
Skin candida
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Infections and infestations
Tonsillitis
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
2/12 • 12 months
|
0.00%
0/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Injury, poisoning and procedural complications
Wound
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Investigations
Neutrophil count decreased
|
16.7%
2/12 • 12 months
|
0.00%
0/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Investigations
Weight decreased
|
0.00%
0/12 • 12 months
|
33.3%
2/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Investigations
Haematocrit decreased
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Investigations
Haemoglobin decreased
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Investigations
Red blood cell count decreased
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Investigations
White blood cell count decreased
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.0%
6/12 • 12 months
|
83.3%
5/6 • 12 months
|
61.1%
11/18 • 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
4/12 • 12 months
|
33.3%
2/6 • 12 months
|
33.3%
6/18 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
3/12 • 12 months
|
50.0%
3/6 • 12 months
|
33.3%
6/18 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
1/12 • 12 months
|
16.7%
1/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/12 • 12 months
|
33.3%
2/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
3/12 • 12 months
|
0.00%
0/6 • 12 months
|
16.7%
3/18 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • 12 months
|
16.7%
1/6 • 12 months
|
16.7%
3/18 • 12 months
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • 12 months
|
16.7%
1/6 • 12 months
|
16.7%
3/18 • 12 months
|
|
Nervous system disorders
Burning sensation
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Nervous system disorders
Neuropathy peripheral
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Psychiatric disorders
Confusional state
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • 12 months
|
16.7%
1/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
58.3%
7/12 • 12 months
|
16.7%
1/6 • 12 months
|
44.4%
8/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
1/12 • 12 months
|
16.7%
1/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • 12 months
|
16.7%
1/6 • 12 months
|
11.1%
2/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
Nail discomfort
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Surgical and medical procedures
Sinus operation
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Vascular disorders
Deep vein thrombosis
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Vascular disorders
Flushing
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • 12 months
|
0.00%
0/6 • 12 months
|
5.6%
1/18 • 12 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • 12 months
|
16.7%
1/6 • 12 months
|
5.6%
1/18 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There are restrictions to the PI's rights to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER