Trial Outcomes & Findings for Alemtuzumab to Treat Severe Aplastic Anemia (NCT NCT00195624)
NCT ID: NCT00195624
Last Updated: 2020-07-07
Results Overview
Hematological response is defined as no longer satisfying blood count criteria for Severe Aplastic Anemia. Patients were classified as responders if they met two of the following three criteria: ANC greater than 500/ mm'; platelet count greater than 20,000/mm3; and reticulocyte count greater than 40,000/mm3 (60,000/mm3 after January 1993).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
6 months
Results posted on
2020-07-07
Participant Flow
Participant milestones
| Measure |
Refractory
Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy.
|
Relapsed
Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
42
|
|
Overall Study
COMPLETED
|
5
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alemtuzumab to Treat Severe Aplastic Anemia
Baseline characteristics by cohort
| Measure |
Refractory
n=5 Participants
Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy.
|
Relapsed
n=42 Participants
Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsHematological response is defined as no longer satisfying blood count criteria for Severe Aplastic Anemia. Patients were classified as responders if they met two of the following three criteria: ANC greater than 500/ mm'; platelet count greater than 20,000/mm3; and reticulocyte count greater than 40,000/mm3 (60,000/mm3 after January 1993).
Outcome measures
| Measure |
Refractory
n=5 Participants
Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy.
|
Relapsed
n=42 Participants
Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
|
|---|---|---|
|
Number of Participants With Hematological Response at 6 Months
|
0 Participants
|
18 Participants
|
Adverse Events
Refractory
Serious events: 2 serious events
Other events: 4 other events
Deaths: 5 deaths
Relapsed
Serious events: 22 serious events
Other events: 42 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Refractory
n=5 participants at risk
Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy.
|
Relapsed
n=42 participants at risk
Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
1/5 • 6 months
|
35.7%
15/42 • 6 months
|
|
Cardiac disorders
Cardiac failure
|
20.0%
1/5 • 6 months
|
0.00%
0/42 • 6 months
|
|
Cardiac disorders
Presyncope
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Immune system disorders
Allergic transfusion reaction
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Infections and infestations
Fungal infection
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemorrhagic ovarian cyst
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Nervous system disorders
Central nervous system inflammation
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Reproductive system and breast disorders
Vaginal ulceration
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
Other adverse events
| Measure |
Refractory
n=5 participants at risk
Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy.
|
Relapsed
n=42 participants at risk
Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Ecchymosis
|
0.00%
0/5 • 6 months
|
14.3%
6/42 • 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/5 • 6 months
|
33.3%
14/42 • 6 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Blood and lymphatic system disorders
Petechiae
|
20.0%
1/5 • 6 months
|
16.7%
7/42 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
1/5 • 6 months
|
0.00%
0/42 • 6 months
|
|
Blood and lymphatic system disorders
Transfusion reaction
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Cardiac disorders
Chest discomfort
|
0.00%
0/5 • 6 months
|
7.1%
3/42 • 6 months
|
|
Cardiac disorders
Chest pain
|
0.00%
0/5 • 6 months
|
7.1%
3/42 • 6 months
|
|
Cardiac disorders
Dizziness
|
0.00%
0/5 • 6 months
|
14.3%
6/42 • 6 months
|
|
Cardiac disorders
Dyspnoea
|
0.00%
0/5 • 6 months
|
14.3%
6/42 • 6 months
|
|
Cardiac disorders
Dyspnoea exertional
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Endocrine disorders
Hyperglycaemia
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
1/5 • 6 months
|
0.00%
0/42 • 6 months
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Eye disorders
Eye irritation
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Eye disorders
Eye pain
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Eye disorders
Eye swelling
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Eye disorders
Visual impairment
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • 6 months
|
14.3%
6/42 • 6 months
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • 6 months
|
7.1%
3/42 • 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/5 • 6 months
|
11.9%
5/42 • 6 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • 6 months
|
19.0%
8/42 • 6 months
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
1/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • 6 months
|
9.5%
4/42 • 6 months
|
|
General disorders
Asthenia
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
General disorders
Catheter site pain
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
General disorders
Chills
|
0.00%
0/5 • 6 months
|
35.7%
15/42 • 6 months
|
|
General disorders
Cold sweat
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
General disorders
Decreased appetite
|
20.0%
1/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
General disorders
Discomfort
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/5 • 6 months
|
28.6%
12/42 • 6 months
|
|
General disorders
Feeling cold
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
General disorders
Flushing
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
General disorders
Hot flush
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
General disorders
Hyperhidrosis
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
General disorders
Infusion related reaction
|
80.0%
4/5 • 6 months
|
59.5%
25/42 • 6 months
|
|
General disorders
Injection site inflammation
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
General disorders
Night sweats
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
General disorders
Pain
|
0.00%
0/5 • 6 months
|
16.7%
7/42 • 6 months
|
|
General disorders
Pallor
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
General disorders
Peripheral coldness
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
General disorders
Pyrexia
|
0.00%
0/5 • 6 months
|
38.1%
16/42 • 6 months
|
|
Immune system disorders
Allergic sinusitis
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Immune system disorders
Bronchospasm
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Immune system disorders
Urticaria
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
2/5 • 6 months
|
14.3%
6/42 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • 6 months
|
26.2%
11/42 • 6 months
|
|
Injury, poisoning and procedural complications
Iron overload
|
0.00%
0/5 • 6 months
|
11.9%
5/42 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Investigations
Blood calcium decreased
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Investigations
Blood pressure decreased
|
0.00%
0/5 • 6 months
|
7.1%
3/42 • 6 months
|
|
Investigations
Blood urine present
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Investigations
Cardiac murmur
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Investigations
Heart rate increased
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Investigations
Liver function test increased
|
0.00%
0/5 • 6 months
|
14.3%
6/42 • 6 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Investigations
Respiratory rate increased
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Investigations
Transaminases
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Investigations
Transaminases increased
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Investigations
Weight decreased
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • 6 months
|
7.1%
3/42 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
20.0%
1/5 • 6 months
|
0.00%
0/42 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dermal cyst
|
20.0%
1/5 • 6 months
|
0.00%
0/42 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • 6 months
|
23.8%
10/42 • 6 months
|
|
Nervous system disorders
Insomnia
|
0.00%
0/5 • 6 months
|
7.1%
3/42 • 6 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/5 • 6 months
|
7.1%
3/42 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • 6 months
|
23.8%
10/42 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • 6 months
|
7.1%
3/42 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of upper respiratory secretion
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • 6 months
|
7.1%
3/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • 6 months
|
23.8%
10/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/5 • 6 months
|
19.0%
8/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin Infiltration
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Vascular disorders
Aortic dilatation
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/5 • 6 months
|
4.8%
2/42 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • 6 months
|
2.4%
1/42 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place