Trial Outcomes & Findings for A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer (NCT NCT00055471)
NCT ID: NCT00055471
Last Updated: 2012-10-31
Results Overview
DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment. The numbers of patients with a DLT are reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Baseline to Day 29.
Results posted on
2012-10-31
Participant Flow
22 male patients with metastatic prostate cancer and rising Prostate Specific Antigen (PSA) levels were recruited from 11th June 2003 (last subject completed on 31st October 2005). This study was conducted in 2 centres in the United States.
6 of the 22 screened patients were not entered into the study as they did not fulfill the study eligibility criteria.
Participant milestones
| Measure |
ZD4054 10 mg
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
|---|---|---|---|
|
Period 1: Dose Escalation Period
STARTED
|
3
|
10
|
3
|
|
Period 1: Dose Escalation Period
COMPLETED
|
3
|
8
|
0
|
|
Period 1: Dose Escalation Period
NOT COMPLETED
|
0
|
2
|
3
|
|
Period 2: Extension Period
STARTED
|
3
|
6
|
0
|
|
Period 2: Extension Period
COMPLETED
|
3
|
6
|
0
|
|
Period 2: Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
ZD4054 10 mg
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
|---|---|---|---|
|
Period 1: Dose Escalation Period
Adverse Event
|
0
|
1
|
2
|
|
Period 1: Dose Escalation Period
Erroneously reported discont. criteria
|
0
|
0
|
1
|
|
Period 1: Dose Escalation Period
Disease progression
|
0
|
1
|
0
|
Baseline Characteristics
A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
ZD4054 10 mg
n=3 Participants
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
n=10 Participants
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
n=3 Participants
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
Overall
|
72.3 Years
STANDARD_DEVIATION 3.21 • n=5 Participants
|
64.6 Years
STANDARD_DEVIATION 9.72 • n=7 Participants
|
66.3 Years
STANDARD_DEVIATION 8.08 • n=5 Participants
|
66.4 Years
STANDARD_DEVIATION 8.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Height
|
177.33 Centimeters (cm)
STANDARD_DEVIATION 4.51 • n=5 Participants
|
177.10 Centimeters (cm)
STANDARD_DEVIATION 8.02 • n=7 Participants
|
176.33 Centimeters (cm)
STANDARD_DEVIATION 5.03 • n=5 Participants
|
177 Centimeters (cm)
STANDARD_DEVIATION 6.69 • n=4 Participants
|
|
Weight
|
87.33 Kilograms (kg)
STANDARD_DEVIATION 19.035 • n=5 Participants
|
107.8 Kilograms (kg)
STANDARD_DEVIATION 21.060 • n=7 Participants
|
103.00 Kilograms (kg)
STANDARD_DEVIATION 35.595 • n=5 Participants
|
103.06 Kilograms (kg)
STANDARD_DEVIATION 23.405 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 29.DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment. The numbers of patients with a DLT are reported.
Outcome measures
| Measure |
ZD4054 10 mg
n=3 Participants
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
n=10 Participants
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
n=3 Participants
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
|---|---|---|---|
|
Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 15.Population: All dosed patients.
Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).
Outcome measures
| Measure |
ZD4054 10 mg
n=3 Participants
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
n=10 Participants
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
n=2 Participants
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
|---|---|---|---|
|
Total Prostate Specific Antigen (PSA) Concentration
|
98.454 ng/ml
Interval 78.0 to 142.6
|
62.366 ng/ml
Interval 6.0 to 448.9
|
56.550 ng/ml
Interval 36.8 to 86.9
|
SECONDARY outcome
Timeframe: Baseline to Day 15.Population: The analysis population includes only patients dosed with ZD4054
Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = \[(measure at Day 15 - measure at baseline)/measure at baseline\]\*100
Outcome measures
| Measure |
ZD4054 10 mg
n=3 Participants
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
n=10 Participants
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
n=2 Participants
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
|---|---|---|---|
|
Change in Total Prostate Specific Antigen (PSA)
|
2.235 Percentage Change
Standard Deviation 15.445
|
10.986 Percentage Change
Standard Deviation 21.345
|
18.404 Percentage Change
Standard Deviation 30.132
|
SECONDARY outcome
Timeframe: Baseline to Day 15.Population: The analysis population includes only patients dosed with ZD4054
Percentage change in serum concentration of Bone Alkaline Phosphatase (ALP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = \[(measure at Day 15 - measure at baseline)/measure at baseline\]\*100
Outcome measures
| Measure |
ZD4054 10 mg
n=3 Participants
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
n=10 Participants
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
n=2 Participants
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
|---|---|---|---|
|
Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)
|
-6.161 Percentage Change
Standard Deviation 9.616
|
-9.197 Percentage Change
Standard Deviation 12.220
|
-9.182 Percentage Change
Standard Deviation 10.644
|
SECONDARY outcome
Timeframe: Baseline to Day 15.Population: The analysis population includes only patients dosed with ZD4054
Percentage change in serum concentration of Procollagen Type I N Propeptide (PINP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = \[(measure at Day 15 - measure at baseline)/measure at baseline\]\*100
Outcome measures
| Measure |
ZD4054 10 mg
n=3 Participants
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
n=10 Participants
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
n=2 Participants
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
|---|---|---|---|
|
Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)
|
7.865 Percentage Change
Standard Deviation 14.625
|
20.681 Percentage Change
Standard Deviation 44.217
|
113.012 Percentage Change
Standard Deviation 51.302
|
SECONDARY outcome
Timeframe: Baseline to Day 15.Population: The analysis population includes only patients dosed with ZD4054
Percentage change in serum concentration of C-Terminal Telopeptide of Type I Collagen (CTx) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = \[(measure at Day 15 - measure at baseline)/measure at baseline\]\*100
Outcome measures
| Measure |
ZD4054 10 mg
n=3 Participants
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
n=10 Participants
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
n=2 Participants
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
|---|---|---|---|
|
Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)
|
-13.832 Percentage Change
Standard Deviation 19.003
|
44.855 Percentage Change
Standard Deviation 94.876
|
20.386 Percentage Change
Standard Deviation 31.094
|
SECONDARY outcome
Timeframe: Baseline to Day 15.Population: The analysis population includes only patients dosed with ZD4054
Percentage change in urine concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) (nmol BCE/mmol Creatinine) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = \[(measure at Day 15 - measure at baseline)/measure at baseline\]\*100
Outcome measures
| Measure |
ZD4054 10 mg
n=3 Participants
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
n=10 Participants
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
n=2 Participants
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
|---|---|---|---|
|
Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)
|
-25.213 Percentage Change
Standard Deviation 15.389
|
2.154 Percentage Change
Standard Deviation 41.900
|
-5.942 Percentage Change
Standard Deviation 34.344
|
Adverse Events
ZD4054 10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ZD4054 15 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
ZD4054 22.5 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZD4054 10 mg
n=3 participants at risk
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
n=10 participants at risk
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
n=3 participants at risk
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Nervous system disorders
Intraventricular Haemorrhage
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
General disorders
Pitting Oedema
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
Other adverse events
| Measure |
ZD4054 10 mg
n=3 participants at risk
ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
|
ZD4054 15 mg
n=10 participants at risk
ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
|
ZD4054 22.5 mg
n=3 participants at risk
ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/3
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Eye disorders
Cataract
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/3
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Eye disorders
Photophobia
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3
|
20.0%
2/10
|
33.3%
1/3
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3
|
10.0%
1/10
|
33.3%
1/3
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
30.0%
3/10
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
|
20.0%
2/10
|
0.00%
0/3
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Gastrointestinal disorders
Tongue Discolouration
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
General disorders
Fatigue
|
0.00%
0/3
|
40.0%
4/10
|
100.0%
3/3
|
|
General disorders
Oedema Peripheral
|
0.00%
0/3
|
90.0%
9/10
|
33.3%
1/3
|
|
General disorders
Chills
|
0.00%
0/3
|
10.0%
1/10
|
33.3%
1/3
|
|
General disorders
Oedema
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/3
|
|
General disorders
Face Oedema
|
0.00%
0/3
|
30.0%
3/10
|
0.00%
0/3
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Injury, poisoning and procedural complications
Barotrauma
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Contrast Media Reaction
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Injury, poisoning and procedural complications
Weight Increased
|
0.00%
0/3
|
10.0%
1/10
|
33.3%
1/3
|
|
Injury, poisoning and procedural complications
Weight Decreased
|
33.3%
1/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Electrocardiogram Qt Corrected Interval Prolonged
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Injury, poisoning and procedural complications
Haemoglobin Decreased
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Injury, poisoning and procedural complications
Heart Rate Increased
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3
|
20.0%
2/10
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3
|
20.0%
2/10
|
66.7%
2/3
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
33.3%
1/3
|
10.0%
1/10
|
66.7%
2/3
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Nervous system disorders
Headache
|
66.7%
2/3
|
90.0%
9/10
|
100.0%
3/3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
10.0%
1/10
|
33.3%
1/3
|
|
Nervous system disorders
Burning Sensation
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/3
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
20.0%
2/10
|
0.00%
0/3
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/3
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
20.0%
2/10
|
0.00%
0/3
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Testicular Pain
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/3
|
20.0%
2/10
|
66.7%
2/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
10.0%
1/10
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
33.3%
1/3
|
30.0%
3/10
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/3
|
20.0%
2/10
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
10.0%
1/10
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Periorbital Oedema
|
0.00%
0/3
|
20.0%
2/10
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Vascular disorders
Flushing
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/3
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
1/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60