Trial Outcomes & Findings for A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel (NCT NCT04035473)
NCT ID: NCT04035473
Last Updated: 2022-04-13
Results Overview
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel. Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine AUC0-∞ by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)
Results posted on
2022-04-13
Participant Flow
45 subjects signed ICF. 3 subjects were screening failures and 42 were randomized. All of the screen failure subjects failed to meet inclusion or exclusion criteria
Participant milestones
| Measure |
Sequence A (Oraxol, IV Paclitaxel)
Oraxol (15 mg HM30181AK-US tablet + 205 mg/m2 paclitaxel capsules) on Days 1, 2, and 3 of Treatment Period 1 followed by 80 mg/m2 IV paclitaxel on Day 1 of Treatment Period 2
|
Sequence B (IV Paclitaxel, Oraxol)
80 mg/m2 IV paclitaxel on Day 1 of Treatment Period 1 followed by Oraxol (15 mg HM30181AK-US tablet + 205 mg/m2 paclitaxel capsules) on Days 1, 2, and 3 of Treatment Period 2
|
|---|---|---|
|
Screening/Baseline
STARTED
|
20
|
22
|
|
Screening/Baseline
COMPLETED
|
20
|
20
|
|
Screening/Baseline
NOT COMPLETED
|
0
|
2
|
|
Treatment Period 1
STARTED
|
20
|
20
|
|
Treatment Period 1
COMPLETED
|
20
|
20
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2
STARTED
|
18
|
19
|
|
Treatment Period 2
COMPLETED
|
18
|
19
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
|
Follow-up Period
STARTED
|
18
|
19
|
|
Follow-up Period
COMPLETED
|
16
|
19
|
|
Follow-up Period
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Sequence A (Oraxol, IV Paclitaxel)
Oraxol (15 mg HM30181AK-US tablet + 205 mg/m2 paclitaxel capsules) on Days 1, 2, and 3 of Treatment Period 1 followed by 80 mg/m2 IV paclitaxel on Day 1 of Treatment Period 2
|
Sequence B (IV Paclitaxel, Oraxol)
80 mg/m2 IV paclitaxel on Day 1 of Treatment Period 1 followed by Oraxol (15 mg HM30181AK-US tablet + 205 mg/m2 paclitaxel capsules) on Days 1, 2, and 3 of Treatment Period 2
|
|---|---|---|
|
Screening/Baseline
Death
|
0
|
1
|
|
Screening/Baseline
Adverse Event
|
0
|
1
|
|
Follow-up Period
Adverse Event
|
2
|
0
|
Baseline Characteristics
A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel
Baseline characteristics by cohort
| Measure |
Sequence A (Oraxol, IV Paclitaxel)
n=20 Participants
Oraxol (15 mg HM30181AK-US tablet + 205 mg/m2 paclitaxel capsules) on Days 1, 2, and 3 of Treatment Period 1 followed by 80 mg/m2 IV paclitaxel on Day 1 of Treatment Period 2
|
Sequence B (IV Paclitaxel, Oraxol)
n=20 Participants
80 mg/m2 IV paclitaxel on Day 1 of Treatment Period 1 followed by Oraxol (15 mg HM30181AK-US tablet + 205 mg/m2 paclitaxel capsules) on Days 1, 2, and 3 of Treatment Period 2
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 10.12 • n=5 Participants
|
59.85 years
STANDARD_DEVIATION 12.14 • n=7 Participants
|
60.33 years
STANDARD_DEVIATION 11.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Weight
|
70.89 kg
STANDARD_DEVIATION 15.45 • n=5 Participants
|
75.42 kg
STANDARD_DEVIATION 15.32 • n=7 Participants
|
73.16 kg
STANDARD_DEVIATION 15.36 • n=5 Participants
|
|
Height
|
166.13 cm
STANDARD_DEVIATION 8.50 • n=5 Participants
|
166.05 cm
STANDARD_DEVIATION 7.82 • n=7 Participants
|
166.09 cm
STANDARD_DEVIATION 8.06 • n=5 Participants
|
|
Body Surface Area
|
1.78 m^2
STANDARD_DEVIATION 0.20 • n=5 Participants
|
1.84 m^2
STANDARD_DEVIATION 0.20 • n=7 Participants
|
1.81 m^2
STANDARD_DEVIATION 0.20 • n=5 Participants
|
|
ECOG
0
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
ECOG
1
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
ECOG
2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG
3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG
4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG
5
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Tumor Stage at Screening
Stage II
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Tumor Stage at Screening
Stage III
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Tumor Stage at Screening
Stage IV
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Tumor Stage at Screening
Not Applicable
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Metastatic Site
Bone
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Metastatic Site
Kidney
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Metastatic Site
Lungs
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Metastatic Site
Lymph Nodes
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Metastatic Site
Liver
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Metastatic Site
Other
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)Population: The 35 randomized subjects completed the study and made up the PK Analysis Set
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel. Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine AUC0-∞ by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
Outcome measures
| Measure |
Oraxol
n=35 Participants
615 mg/m2 over 3 Consecutive Days Administered as Oraxol
|
IV Paclitaxel
n=35 Participants
IV paclitaxel (80 mg/m2) infused over 1 hour
|
|---|---|---|
|
Area Under the Concentration-Time Curve Zero Time Extrapolated to Infinite Time (AUC0-∞)
|
5033.5 ng*h/mL
Standard Deviation 1401.1
|
5595.9 ng*h/mL
Standard Deviation 264.1
|
SECONDARY outcome
Timeframe: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)Population: The 35 randomized subjects completed the study and made up the PK Analysis Set
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel. Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine Cmax by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
Outcome measures
| Measure |
Oraxol
n=35 Participants
615 mg/m2 over 3 Consecutive Days Administered as Oraxol
|
IV Paclitaxel
n=35 Participants
IV paclitaxel (80 mg/m2) infused over 1 hour
|
|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
397.2 ng/mL
Standard Deviation 157.3
|
2732.8 ng/mL
Standard Deviation 629.7
|
SECONDARY outcome
Timeframe: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)Population: The 35 randomized subjects completed the study and made up the PK Analysis Set
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel. Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine AUC0-t by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
Outcome measures
| Measure |
Oraxol
n=35 Participants
615 mg/m2 over 3 Consecutive Days Administered as Oraxol
|
IV Paclitaxel
n=35 Participants
IV paclitaxel (80 mg/m2) infused over 1 hour
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)
|
4829.4 ng*h/mL
Standard Deviation 1375.1
|
5431.8 ng*h/mL
Standard Deviation 1200.3
|
SECONDARY outcome
Timeframe: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)Population: The 35 randomized subjects completed the study and made up the PK Analysis Set
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel. Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine Tmax by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
Outcome measures
| Measure |
Oraxol
n=35 Participants
615 mg/m2 over 3 Consecutive Days Administered as Oraxol
|
IV Paclitaxel
n=35 Participants
IV paclitaxel (80 mg/m2) infused over 1 hour
|
|---|---|---|
|
Time at Which the Highest Drug Concentration Occurs (Tmax)
|
1.4 hours
Standard Deviation 0.6
|
1.0 hours
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)Population: The 35 randomized subjects completed the study and made up the PK Analysis Set
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel. Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine t½ by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
Outcome measures
| Measure |
Oraxol
n=35 Participants
615 mg/m2 over 3 Consecutive Days Administered as Oraxol
|
IV Paclitaxel
n=35 Participants
IV paclitaxel (80 mg/m2) infused over 1 hour
|
|---|---|---|
|
Terminal Elimination Phase Half-life (t½)
|
42.8 hours
Standard Deviation 8.6
|
26.1 hours
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: From screening until final visit (within 28 days after the last dose of study drug was taken, and preferably before the participant receives any additional chemotherapy)Population: 40 subjects received study drug (39 received at least 1 dose of Oraxol and 38 received 1 dose of IV paclitaxel) and had at least 1 postdose safety assessment
Safety was assessed by recording all adverse events (AEs) and serious adverse events (SAEs), including CTCAE grades (version 4.03); recording concomitant medications; clinical laboratory testing (including hematology, biochemistry, and urinalysis); measurement of vital signs (pulse rate, systolic and diastolic blood pressures, respiratory rate, and body temperature), weight, and body surface area (BSA); performance of electrocardiograms (ECGs); assessment of ECOG performance status; and performance of physical examinations
Outcome measures
| Measure |
Oraxol
n=39 Participants
615 mg/m2 over 3 Consecutive Days Administered as Oraxol
|
IV Paclitaxel
n=38 Participants
IV paclitaxel (80 mg/m2) infused over 1 hour
|
|---|---|---|
|
Safety and Tolerability of Oraxol Compared With IV Paclitaxel
TEAE
|
36 Participants
|
29 Participants
|
|
Safety and Tolerability of Oraxol Compared With IV Paclitaxel
Treatment-related TEAE
|
30 Participants
|
20 Participants
|
|
Safety and Tolerability of Oraxol Compared With IV Paclitaxel
TEAE resulting in death
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Oraxol Compared With IV Paclitaxel
Grade 3 TEAE
|
7 Participants
|
2 Participants
|
|
Safety and Tolerability of Oraxol Compared With IV Paclitaxel
TEAE leading to study drug discontinuation
|
1 Participants
|
2 Participants
|
|
Safety and Tolerability of Oraxol Compared With IV Paclitaxel
TEAE leading to study discontinuation
|
0 Participants
|
2 Participants
|
Adverse Events
Oraxol
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
IV Paclitaxel
Serious events: 2 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Oraxol
n=39 participants at risk
Oraxol (15 mg HM30181A + oral paclitaxel 205 mg/m2) for 3 consecutive days.
|
IV Paclitaxel
n=38 participants at risk
IV Pacllitaxel 80 mg/m2 for 1 day.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Cardiac disorders
Cardiac tamponade
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Cardiac disorders
Tachycardia
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Infections and infestations
Septic shock
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Renal and urinary disorders
Haematuria
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Vascular disorders
Circulatory collapse
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Vascular disorders
Hypotension
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
Other adverse events
| Measure |
Oraxol
n=39 participants at risk
Oraxol (15 mg HM30181A + oral paclitaxel 205 mg/m2) for 3 consecutive days.
|
IV Paclitaxel
n=38 participants at risk
IV Pacllitaxel 80 mg/m2 for 1 day.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
28.2%
11/39 • Number of events 11 • up to 7 weeks
|
18.4%
7/38 • Number of events 7 • up to 7 weeks
|
|
Gastrointestinal disorders
Nausea
|
28.2%
11/39 • Number of events 11 • up to 7 weeks
|
7.9%
3/38 • Number of events 3 • up to 7 weeks
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
5/39 • Number of events 6 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
2/39 • Number of events 2 • up to 7 weeks
|
5.3%
2/38 • Number of events 2 • up to 7 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/39 • up to 7 weeks
|
5.3%
2/38 • Number of events 2 • up to 7 weeks
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
2/39 • Number of events 2 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.1%
2/39 • Number of events 2 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Gastrointestinal disorders
Epigastric discomfort
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Gastrointestinal disorders
Oral pain
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Gastrointestinal disorders
Swollen tongue
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Gastrointestinal disorders
Toothache
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
General disorders
Fatigue
|
15.4%
6/39 • Number of events 6 • up to 7 weeks
|
5.3%
2/38 • Number of events 2 • up to 7 weeks
|
|
General disorders
Pyrexia
|
5.1%
2/39 • Number of events 2 • up to 7 weeks
|
2.6%
1/38 • Number of events 2 • up to 7 weeks
|
|
General disorders
Injection site pruritus
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
General disorders
Medical device site irritation
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
General disorders
Medical device site rash
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Nervous system disorders
Headache
|
7.7%
3/39 • Number of events 3 • up to 7 weeks
|
5.3%
2/38 • Number of events 2 • up to 7 weeks
|
|
Nervous system disorders
Dizziness
|
5.1%
2/39 • Number of events 3 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
5.3%
2/38 • Number of events 2 • up to 7 weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
5.3%
2/38 • Number of events 2 • up to 7 weeks
|
|
Nervous system disorders
Dysgeusia
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Number of events 2 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/39 • up to 7 weeks
|
5.3%
2/38 • Number of events 2 • up to 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
3/39 • Number of events 3 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
2/39 • Number of events 2 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Dysphonia
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Vascular disorders
Flushing
|
0.00%
0/39 • up to 7 weeks
|
13.2%
5/38 • Number of events 5 • up to 7 weeks
|
|
Vascular disorders
Thrombophlebitis
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Vascular disorders
Thrombosis
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.1%
2/39 • Number of events 2 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Infections and infestations
Cellulitis
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.1%
2/39 • Number of events 2 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
5.1%
2/39 • Number of events 2 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Renal and urinary disorders
Chromaturia
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Renal and urinary disorders
Dysuria
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Investigations
Blood calcium increased
|
5.1%
2/39 • Number of events 2 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Investigations
Neutrophil count decreased
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Investigations
White blood cell count decreased
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
|
Eye disorders
Lacrimation increased
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Eye disorders
Visual impairment
|
2.6%
1/39 • Number of events 1 • up to 7 weeks
|
0.00%
0/38 • up to 7 weeks
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/39 • up to 7 weeks
|
2.6%
1/38 • Number of events 1 • up to 7 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place