Trial Outcomes & Findings for Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer (NCT NCT00098345)
NCT ID: NCT00098345
Last Updated: 2018-05-07
Results Overview
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Results posted on
2018-05-07
Participant Flow
First patient enrolled 12 November 2004, last patient enrolled 15 August 2006, cut off date 22 February 2008. 40 patients were enrolled in the study.
40 patients were enrolled/screened to the study but only 30 patients were entered treatment/randomized.
Participant milestones
| Measure |
Caprelsa (Vandetanib) 300 mg
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Caprelsa (Vandetanib) 300 mg
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
progression
|
4
|
Baseline Characteristics
Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Caprelsa (Vandetanib) 300 mg
n=30 Participants
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
Age, Continuous
|
48.7 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.
Outcome measures
| Measure |
Caprelsa (Vandetanib) 300 mg
n=30 Participants
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
Objective Response Rate
|
6 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.Population: Upper limit is a censored value
Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.
Outcome measures
| Measure |
Caprelsa (Vandetanib) 300 mg
n=30 Participants
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
Progression Free Survival
|
27.9 months
Interval 2.56 to 36.11
|
SECONDARY outcome
Timeframe: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days.
Outcome measures
| Measure |
Caprelsa (Vandetanib) 300 mg
n=30 Participants
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
Duration of Objective Response
|
310.5 days
Interval 245.0 to 402.0
|
SECONDARY outcome
Timeframe: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0.
Outcome measures
| Measure |
Caprelsa (Vandetanib) 300 mg
n=30 Participants
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
Disease Control Rate
|
22 Participants
|
SECONDARY outcome
Timeframe: Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuationA patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline).
Outcome measures
| Measure |
Caprelsa (Vandetanib) 300 mg
n=30 Participants
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
Biochemical Response Calcitonin (CTN)
|
24 Participants
|
SECONDARY outcome
Timeframe: Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug.Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR.
Outcome measures
| Measure |
Caprelsa (Vandetanib) 300 mg
n=30 Participants
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
Symptomatic Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated.Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled)
Outcome measures
| Measure |
Caprelsa (Vandetanib) 300 mg
n=30 Participants
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
World Health Organisation (WHO) Performance Status
|
4 Participants
|
Adverse Events
Caprelsa (Vandetanib) 300 mg
Serious events: 14 serious events
Other events: 30 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Caprelsa (Vandetanib) 300 mg
n=30 participants at risk
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
Cardiac disorders
Cardiac Failure
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Diarrhoea Haemorrhagic
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Death
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Abdominal Infection
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Cystitis
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Diverticulitis Intestinal Haemorrhagic
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Empyema
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Investigations
Electrocardiogram Qt Prolonged
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Nervous system disorders
Neuropathy Peripheral
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Nervous system disorders
Seizure
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Exfoliative Rash
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Vascular disorders
Embolism
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Vascular disorders
Hot Flush
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Vascular disorders
Hypotension
|
3.3%
1/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
Other adverse events
| Measure |
Caprelsa (Vandetanib) 300 mg
n=30 participants at risk
Daily oral dose of Caprelsa (vandetanib) 300mg
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Cardiac disorders
Bradycardia
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Cardiac disorders
Palpitations
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Eye disorders
Conjunctivitis
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Eye disorders
Dry Eye
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Eye disorders
Vision Blurred
|
23.3%
7/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Eye disorders
Visual Disturbance
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
6/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Constipation
|
36.7%
11/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
70.0%
21/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Dry Mouth
|
16.7%
5/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
6/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Nausea
|
63.3%
19/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Oesophagitis
|
20.0%
6/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
12/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Asthenia
|
20.0%
6/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Chest Discomfort
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Chills
|
16.7%
5/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Face Oedema
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Fatigue
|
63.3%
19/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Influenza Like Illness
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Localised Oedema
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Mucosal Inflammation
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Oedema
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Oedema Peripheral
|
23.3%
7/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Pyrexia
|
13.3%
4/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
General disorders
Temperature Intolerance
|
20.0%
6/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Bronchitis
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Laryngitis
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Paronychia
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Sinusitis
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
13.3%
4/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Infections and infestations
Urinary Tract Infection
|
23.3%
7/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Injury, poisoning and procedural complications
Contrast Media Reaction
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Investigations
Blood Creatinine Increased
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Investigations
Blood Urea Increased
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Investigations
Electrocardiogram Qt Prolonged
|
23.3%
7/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Investigations
Platelet Count Increased
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Investigations
Weight Decreased
|
13.3%
4/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Investigations
Weight Increased
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
43.3%
13/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
4/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
23.3%
7/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
4/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Nervous system disorders
Dizziness
|
26.7%
8/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
10/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Nervous system disorders
Dyskinesia
|
16.7%
5/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Nervous system disorders
Headache
|
46.7%
14/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Nervous system disorders
Tremor
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Psychiatric disorders
Anxiety
|
20.0%
6/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Psychiatric disorders
Depression
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Psychiatric disorders
Insomnia
|
20.0%
6/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Renal and urinary disorders
Haematuria
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Renal and urinary disorders
Nephrolithiasis
|
13.3%
4/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Renal and urinary disorders
Urinary Retention
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.3%
7/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
6/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
20.0%
6/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Acne
|
20.0%
6/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
5/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
13.3%
4/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
16.7%
5/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
30.0%
9/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Periorbital Oedema
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
20.0%
6/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
4/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
20/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
6.7%
2/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Vascular disorders
Flushing
|
10.0%
3/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Vascular disorders
Hot Flush
|
13.3%
4/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
|
Vascular disorders
Hypertension
|
33.3%
10/30
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER