Trial Outcomes & Findings for Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2 (NCT NCT04345900)
NCT ID: NCT04345900
Last Updated: 2024-05-16
Results Overview
Duration of Grade 4 neutropenia (ANC \< 0.5 × 109/L)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
At the end of Cycle 1 (each cycle is 21 days)
Results posted on
2024-05-16
Participant Flow
Participant milestones
| Measure |
Arm 1
75 mg/m\^2 Docetaxel + 6 mg Pegfilgrastim
|
Arm 2
75 mg/m\^2 Docetaxel + 20 mg/m\^2 Plinabulin
|
Arm 3
75 mg/m\^2 Docetaxel + 10 mg/m\^2 Plinabulin
|
Arm 4
75 mg/m\^2 Docetaxel + 5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
14
|
14
|
|
Overall Study
COMPLETED
|
11
|
11
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2
Baseline characteristics by cohort
| Measure |
Arm 1
n=13 Participants
75 mg/m\^2 Docetaxel + 6 mg Pegfilgrastim
|
Arm 2
n=14 Participants
75 mg/m\^2 Docetaxel + 20 mg/m\^2 Plinabulin
|
Arm 3
n=14 Participants
75 mg/m\^2 Docetaxel + 10 mg/m\^2 Plinabulin
|
Arm 4
n=14 Participants
75 mg/m\^2 Docetaxel + 5 mg/m\^2 Plinabulin
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Age, Continuous
|
59.5 Years
STANDARD_DEVIATION 8.08 • n=99 Participants
|
63.0 Years
STANDARD_DEVIATION 10.44 • n=107 Participants
|
58.6 Years
STANDARD_DEVIATION 11.72 • n=206 Participants
|
64.1 Years
STANDARD_DEVIATION 10.33 • n=7 Participants
|
61.3 Years
STANDARD_DEVIATION 10.24 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Neutrophil Count at Baseline Visit (Pre-dose)
|
9.766 10^9 Cells/L
STANDARD_DEVIATION 3.4633 • n=99 Participants
|
7.498 10^9 Cells/L
STANDARD_DEVIATION 2.3376 • n=107 Participants
|
8.870 10^9 Cells/L
STANDARD_DEVIATION 3.0302 • n=206 Participants
|
8.061 10^9 Cells/L
STANDARD_DEVIATION 3.9371 • n=7 Participants
|
8.527 10^9 Cells/L
STANDARD_DEVIATION 3.2641 • n=31 Participants
|
PRIMARY outcome
Timeframe: At the end of Cycle 1 (each cycle is 21 days)Duration of Grade 4 neutropenia (ANC \< 0.5 × 109/L)
Outcome measures
| Measure |
Arm 1
n=13 Participants
75 mg/m\^2 Docetaxel +6 mg Pegfilgrastim
|
Arm 2
n=14 Participants
75 mg/m\^2 Docetaxel +20 mg/m\^2 Plinabulin
|
Arm 3
n=14 Participants
75 mg/m\^2 Docetaxel +10 mg/m\^2 Plinabulin
|
Arm 4
n=14 Participants
75 mg/m\^2 Docetaxel +5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
DSN
|
0.15 days
Standard Deviation 0.376
|
0.36 days
Standard Deviation 0.929
|
0.43 days
Standard Deviation 1.089
|
0.29 days
Standard Deviation 0.611
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 4.5, 24 hours post-dosePopulation: Arm 1 is the positive placebo group
a parameter to establish the pharmacokinetic profile of plinabulin by evaluating the peak plasma concentration (Cmax) of the drug in the blood after administration of a single dose of the drug
Outcome measures
| Measure |
Arm 1
75 mg/m\^2 Docetaxel +6 mg Pegfilgrastim
|
Arm 2
n=14 Participants
75 mg/m\^2 Docetaxel +20 mg/m\^2 Plinabulin
|
Arm 3
n=14 Participants
75 mg/m\^2 Docetaxel +10 mg/m\^2 Plinabulin
|
Arm 4
n=14 Participants
75 mg/m\^2 Docetaxel +5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax)
|
—
|
0.263 mg/L
Standard Deviation 0.173
|
0.131 mg/L
Standard Deviation 0.086
|
0.066 mg/L
Standard Deviation 0.043
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 4.5, 24 hours post-dosePopulation: Arm 1 is positive placebo group
A parameter to establish the pharmacokinetic profile of plinabulin to describe the variation of the drug concentration in blood plasma as a function of time
Outcome measures
| Measure |
Arm 1
75 mg/m\^2 Docetaxel +6 mg Pegfilgrastim
|
Arm 2
n=14 Participants
75 mg/m\^2 Docetaxel +20 mg/m\^2 Plinabulin
|
Arm 3
n=14 Participants
75 mg/m\^2 Docetaxel +10 mg/m\^2 Plinabulin
|
Arm 4
n=14 Participants
75 mg/m\^2 Docetaxel +5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
Area Under Curve (AUC)
|
—
|
1.22 mg*hr/L
Standard Deviation 1.56
|
0.61 mg*hr/L
Standard Deviation 0.78
|
0.31 mg*hr/L
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 4.5, 24 hours post-dosePopulation: Arm 1 is positive placebo group
A parameter to establish the pharmacokinetic profile of plinabulin by measuring the time it takes for the concentration of the drug in the plasma to be reduced by 50%
Outcome measures
| Measure |
Arm 1
75 mg/m\^2 Docetaxel +6 mg Pegfilgrastim
|
Arm 2
n=14 Participants
75 mg/m\^2 Docetaxel +20 mg/m\^2 Plinabulin
|
Arm 3
n=14 Participants
75 mg/m\^2 Docetaxel +10 mg/m\^2 Plinabulin
|
Arm 4
n=14 Participants
75 mg/m\^2 Docetaxel +5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
Terminal Half-time (T1/2)
|
—
|
7.38 hrs
Standard Deviation 3.26
|
7.39 hrs
Standard Deviation 1.79
|
7.99 hrs
Standard Deviation 3.69
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 4.5, 24 hours post-dosePopulation: Arm 1 is the positive placebo group
A parameter to establish the pharmacokinetic profile of plinabulin by evaluating Vz.
Outcome measures
| Measure |
Arm 1
75 mg/m\^2 Docetaxel +6 mg Pegfilgrastim
|
Arm 2
n=14 Participants
75 mg/m\^2 Docetaxel +20 mg/m\^2 Plinabulin
|
Arm 3
n=14 Participants
75 mg/m\^2 Docetaxel +10 mg/m\^2 Plinabulin
|
Arm 4
n=14 Participants
75 mg/m\^2 Docetaxel +5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
Volume of Distribution in the Terminal Elimination Phase (Vz)
|
—
|
198 L
Standard Deviation 51
|
248 L
Standard Deviation 72
|
154 L
Standard Deviation 111
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 4.5, 24 hours post-dosePopulation: Arm 1 is positive Placebo group
a parameter to establish the pharmacokinetic profile of plinabulin
Outcome measures
| Measure |
Arm 1
75 mg/m\^2 Docetaxel +6 mg Pegfilgrastim
|
Arm 2
n=14 Participants
75 mg/m\^2 Docetaxel +20 mg/m\^2 Plinabulin
|
Arm 3
n=14 Participants
75 mg/m\^2 Docetaxel +10 mg/m\^2 Plinabulin
|
Arm 4
n=14 Participants
75 mg/m\^2 Docetaxel +5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
Clearance (Cl)
|
—
|
22.9 L/hr
Standard Deviation 18.0
|
25.0 L/hr
Standard Deviation 15.0
|
18.5 L/hr
Standard Deviation 23.7
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 4.5, 24 hours post-dosePopulation: Arm 1 is the positive placebo group
a parameter to establish the pharmacodynamic profile of plinabulin
Outcome measures
| Measure |
Arm 1
75 mg/m\^2 Docetaxel +6 mg Pegfilgrastim
|
Arm 2
n=14 Participants
75 mg/m\^2 Docetaxel +20 mg/m\^2 Plinabulin
|
Arm 3
n=14 Participants
75 mg/m\^2 Docetaxel +10 mg/m\^2 Plinabulin
|
Arm 4
n=14 Participants
75 mg/m\^2 Docetaxel +5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
Systolic Blood Pressure
|
—
|
136 mm Hg
Standard Deviation 24
|
134 mm Hg
Standard Deviation 18.7
|
138 mm Hg
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 4.5, 24 hours post-dosePopulation: Arm 1 is positive placebo group
a parameter to establish the pharmacodynamic profile of plinabulin
Outcome measures
| Measure |
Arm 1
75 mg/m\^2 Docetaxel +6 mg Pegfilgrastim
|
Arm 2
n=14 Participants
75 mg/m\^2 Docetaxel +20 mg/m\^2 Plinabulin
|
Arm 3
n=14 Participants
75 mg/m\^2 Docetaxel +10 mg/m\^2 Plinabulin
|
Arm 4
n=14 Participants
75 mg/m\^2 Docetaxel +5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
Diastolic Blood Pressure
|
—
|
79.2 mm Hg
Standard Deviation 11.6
|
84.1 mm Hg
Standard Deviation 16.8
|
84.8 mm Hg
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 4.5, 24 hours post-dosePopulation: Arm 1 is positive placebo group
a parameter to establish the pharmacodynamic profile of plinabulin
Outcome measures
| Measure |
Arm 1
75 mg/m\^2 Docetaxel +6 mg Pegfilgrastim
|
Arm 2
n=14 Participants
75 mg/m\^2 Docetaxel +20 mg/m\^2 Plinabulin
|
Arm 3
n=14 Participants
75 mg/m\^2 Docetaxel +10 mg/m\^2 Plinabulin
|
Arm 4
n=14 Participants
75 mg/m\^2 Docetaxel +5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
Area Over the Neutropenia Curve
|
—
|
0.086 mg*hr/L
Standard Deviation 0.815
|
0.111 mg*hr/L
Standard Deviation 0.955
|
0.113 mg*hr/L
Standard Deviation 0.958
|
Adverse Events
Arm 1
Serious events: 2 serious events
Other events: 11 other events
Deaths: 1 deaths
Arm 2
Serious events: 2 serious events
Other events: 12 other events
Deaths: 1 deaths
Arm 3
Serious events: 2 serious events
Other events: 12 other events
Deaths: 1 deaths
Arm 4
Serious events: 2 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1
n=13 participants at risk
75 mg/m\^2 Docetaxel + 6 mg Pegfilgrastim
|
Arm 2
n=14 participants at risk
75 mg/m\^2 Docetaxel + 20 mg/m\^2 Plinabulin
|
Arm 3
n=14 participants at risk
75 mg/m\^2 Docetaxel + 10 mg/m\^2 Plinabulin
|
Arm 4
n=14 participants at risk
75 mg/m\^2 Docetaxel + 5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Asthenia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Disease Progression
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Septic Shock
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
Other adverse events
| Measure |
Arm 1
n=13 participants at risk
75 mg/m\^2 Docetaxel + 6 mg Pegfilgrastim
|
Arm 2
n=14 participants at risk
75 mg/m\^2 Docetaxel + 20 mg/m\^2 Plinabulin
|
Arm 3
n=14 participants at risk
75 mg/m\^2 Docetaxel + 10 mg/m\^2 Plinabulin
|
Arm 4
n=14 participants at risk
75 mg/m\^2 Docetaxel + 5 mg/m\^2 Plinabulin
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
35.7%
5/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.8%
4/13 • Time of screening until 30 day follow up (5 months).
|
35.7%
5/14 • Time of screening until 30 day follow up (5 months).
|
42.9%
6/14 • Time of screening until 30 day follow up (5 months).
|
50.0%
7/14 • Time of screening until 30 day follow up (5 months).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
21.4%
3/14 • Time of screening until 30 day follow up (5 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.1%
3/13 • Time of screening until 30 day follow up (5 months).
|
50.0%
7/14 • Time of screening until 30 day follow up (5 months).
|
35.7%
5/14 • Time of screening until 30 day follow up (5 months).
|
64.3%
9/14 • Time of screening until 30 day follow up (5 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Cardiac disorders
Cardiac Failure
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Cardiac disorders
Myocardial Firbrosis
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Cardiac disorders
Myocardial Ischaemia
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Cardiac disorders
Sinus Tachycardia
|
15.4%
2/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Cardiac disorders
Tachycardia
|
15.4%
2/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Eye disorders
Chalazion
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Eye disorders
Dry Eye
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Eye disorders
Mydriasis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Anal Incontinence
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
21.4%
3/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
28.6%
4/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Oral Mucosal Blistering
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Retching
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Asthenia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Chest Discomfort
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Fatigue
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
21.4%
3/14 • Time of screening until 30 day follow up (5 months).
|
28.6%
4/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Gait Disturbance
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Localized Oedema
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Non-Cardiac Chest Pain
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Oedema
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Odema Peripheral
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Hepatobiliary disorders
Liver Injury
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Angular Cheilitis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Influenza
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Viral Infection
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Investigations
Alanine Aminotransferase increased
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Investigations
Amylase Increased
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Investigations
Blood Glucose Increased
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Infections and infestations
Blood Pressure Increased
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Investigations
Grip Strength Decreased
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Investigations
Weight Decreased
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Investigations
White Blood Cell Count Decreased
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
21.4%
3/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
21.4%
3/14 • Time of screening until 30 day follow up (5 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Nervous system disorders
Complex Regional Pain Syndrome
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Nervous system disorders
Neuropathy Peripheral
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Psychiatric disorders
Mood Altered
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Psychiatric disorders
Urinary Incontinence
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.7%
1/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonry Disease
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.5%
5/13 • Time of screening until 30 day follow up (5 months).
|
28.6%
4/14 • Time of screening until 30 day follow up (5 months).
|
50.0%
7/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Skin and subcutaneous tissue disorders
Haemorrhage Subcutaneous
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Vascular disorders
Flushing
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
28.6%
4/14 • Time of screening until 30 day follow up (5 months).
|
14.3%
2/14 • Time of screening until 30 day follow up (5 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
|
Vascular disorders
Superior Vena Cava Syndrome
|
0.00%
0/13 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
0.00%
0/14 • Time of screening until 30 day follow up (5 months).
|
7.1%
1/14 • Time of screening until 30 day follow up (5 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place