Trial Outcomes & Findings for Extended Dosing With Eltrombopag for Severe Aplastic Anemia (NCT NCT01891994)
NCT ID: NCT01891994
Last Updated: 2023-04-25
Results Overview
Defined as unilineage or multilineage recovery by 1 or more of the following: 1) platelet response (increase to 20 × 103/μL above baseline or stable platelet counts with transfusion independence for a minimum of 8 weeks in those who were transfusion dependent on entry into the protocol); (2) erythroid response (when pretreatment hemoglobin was \<9 g/dL, defined as an increase in hemoglobin by 1.5 g/dL or, in transfused patients, a reduction in the units of packed red blood cell transfusions by an absolute number of at least 4 transfusions for 8 consecutive weeks, compared with the pretreatment transfusion number in the previous 8 weeks); and (3) neutrophil response (when pretreatment absolute neutrophil count \[ANC\] of \<0.5 × 103/μL as at least a 100% increase in ANC, or an ANC increase \>0.5 × 103/μL, and the toxicity profile as measured using Common Terminology Criteria for Adverse Events).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
24 weeks
Results posted on
2023-04-25
Participant Flow
Participant milestones
| Measure |
Eltrombopag
Eltrombopag was administered for 6 months at a dose of 150mg daily in patients \> 12 years of age, 75mg daily for patients 6 to 11 years of age, and 2.5 mg/kg/day for children 2-5 years of age. Dosing was reduced to 50% for patients of East Asian ethnicity.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extended Dosing With Eltrombopag for Severe Aplastic Anemia
Baseline characteristics by cohort
| Measure |
Eltrombopag
n=40 Participants
Eltrombopag was administered for 6 months at a dose of 150mg daily in patients \> 12 years of age, 75mg daily for patients 6 to 11 years of age, and 2.5 mg/kg/day for children 2-5 years of age.
|
|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All subjects who received Eltrombopag were analyzed.
Defined as unilineage or multilineage recovery by 1 or more of the following: 1) platelet response (increase to 20 × 103/μL above baseline or stable platelet counts with transfusion independence for a minimum of 8 weeks in those who were transfusion dependent on entry into the protocol); (2) erythroid response (when pretreatment hemoglobin was \<9 g/dL, defined as an increase in hemoglobin by 1.5 g/dL or, in transfused patients, a reduction in the units of packed red blood cell transfusions by an absolute number of at least 4 transfusions for 8 consecutive weeks, compared with the pretreatment transfusion number in the previous 8 weeks); and (3) neutrophil response (when pretreatment absolute neutrophil count \[ANC\] of \<0.5 × 103/μL as at least a 100% increase in ANC, or an ANC increase \>0.5 × 103/μL, and the toxicity profile as measured using Common Terminology Criteria for Adverse Events).
Outcome measures
| Measure |
Eltrombopag
n=40 Participants
Eltrombopag was administered for 6 months at a dose of 150mg daily in patients \> 12 years of age, 75mg daily for patients 6 to 11 years of age, and 2.5 mg/kg/day for children 2-5 years of age. Dosing was reduced to 50% for patients of East Asian ethnicity.
|
|---|---|
|
Number of Participants With Drug Response as Defined by Clinically-signficant Hematologic Improvements
|
20 Participants
|
Adverse Events
Eltrombopag
Serious events: 13 serious events
Other events: 39 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Eltrombopag
n=40 participants at risk
Eltrombopag was administered for 6 months at a dose of 150mg daily in patients \> 12 years of age, 75mg daily for patients 6 to 11 years of age, and 2.5 mg/kg/day for children 2-5 years of age.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
1/40 • 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
4/40 • 6 months
|
|
Ear and labyrinth disorders
Otitis media
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Colitis
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Pancreatitis
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • 6 months
|
|
General disorders
Death
|
2.5%
1/40 • 6 months
|
|
General disorders
Infusion related reaction
|
2.5%
1/40 • 6 months
|
|
General disorders
Pyrexia
|
2.5%
1/40 • 6 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
2.5%
1/40 • 6 months
|
|
Immune system disorders
Hypersensitivity
|
2.5%
1/40 • 6 months
|
|
Immune system disorders
Urticaria
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Clostridium difficile Infection
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Influenza
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Sepsis
|
5.0%
2/40 • 6 months
|
|
Infections and infestations
Staphylococcal infection
|
2.5%
1/40 • 6 months
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
2.5%
1/40 • 6 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.5%
1/40 • 6 months
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • 6 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.5%
1/40 • 6 months
|
|
Reproductive system and breast disorders
Ovarian haemorrhage
|
2.5%
1/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
1/40 • 6 months
|
|
Surgical and medical procedures
Catheter placement
|
2.5%
1/40 • 6 months
|
|
Surgical and medical procedures
Hip arthroplasty
|
2.5%
1/40 • 6 months
|
Other adverse events
| Measure |
Eltrombopag
n=40 participants at risk
Eltrombopag was administered for 6 months at a dose of 150mg daily in patients \> 12 years of age, 75mg daily for patients 6 to 11 years of age, and 2.5 mg/kg/day for children 2-5 years of age.
|
|---|---|
|
Blood and lymphatic system disorders
Acute Myeloid Leukaemia
|
2.5%
1/40 • 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
16/40 • 6 months
|
|
Blood and lymphatic system disorders
Conjunctival pallor
|
2.5%
1/40 • 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.5%
3/40 • 6 months
|
|
Blood and lymphatic system disorders
Ocular icterus
|
25.0%
10/40 • 6 months
|
|
Blood and lymphatic system disorders
Petechiae
|
22.5%
9/40 • 6 months
|
|
Blood and lymphatic system disorders
Purpura
|
2.5%
1/40 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
2/40 • 6 months
|
|
Cardiac disorders
Dizziness
|
20.0%
8/40 • 6 months
|
|
Cardiac disorders
Dyspnoea
|
20.0%
8/40 • 6 months
|
|
Cardiac disorders
Localised oedema
|
2.5%
1/40 • 6 months
|
|
Cardiac disorders
Oedema peripheral
|
22.5%
9/40 • 6 months
|
|
Cardiac disorders
Palpitations
|
2.5%
1/40 • 6 months
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
1/40 • 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
7.5%
3/40 • 6 months
|
|
Cardiac disorders
Syncope
|
2.5%
1/40 • 6 months
|
|
Ear and labyrinth disorders
Ear Infection
|
2.5%
1/40 • 6 months
|
|
Ear and labyrinth disorders
Ear pain
|
7.5%
3/40 • 6 months
|
|
Ear and labyrinth disorders
External ear inflammation
|
2.5%
1/40 • 6 months
|
|
Ear and labyrinth disorders
Otitis externa
|
5.0%
2/40 • 6 months
|
|
Ear and labyrinth disorders
Otitis media
|
5.0%
2/40 • 6 months
|
|
Eye disorders
Conjunctivitis
|
2.5%
1/40 • 6 months
|
|
Eye disorders
Eye disorder
|
2.5%
1/40 • 6 months
|
|
Eye disorders
Eye irritation
|
2.5%
1/40 • 6 months
|
|
Eye disorders
Macular cyst
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
2/40 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
8/40 • 6 months
|
|
Gastrointestinal disorders
Anogenital warts
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
10.0%
4/40 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
22.5%
9/40 • 6 months
|
|
Gastrointestinal disorders
Dysgeusia
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
10.0%
4/40 • 6 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
2/40 • 6 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Large intestine polyp
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Lip infection
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
10.0%
4/40 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
8/40 • 6 months
|
|
Gastrointestinal disorders
Oral candidiasis
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
2/40 • 6 months
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
7.5%
3/40 • 6 months
|
|
Gastrointestinal disorders
Pelvic pain
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Periodontal disease
|
5.0%
2/40 • 6 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
2/40 • 6 months
|
|
Gastrointestinal disorders
Tooth infection
|
5.0%
2/40 • 6 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.5%
1/40 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • 6 months
|
|
General disorders
Chills
|
12.5%
5/40 • 6 months
|
|
General disorders
Decreased appetite
|
12.5%
5/40 • 6 months
|
|
General disorders
Fatigue
|
7.5%
3/40 • 6 months
|
|
General disorders
Flushing
|
2.5%
1/40 • 6 months
|
|
General disorders
Hot flush
|
7.5%
3/40 • 6 months
|
|
General disorders
Influenza like illness
|
7.5%
3/40 • 6 months
|
|
General disorders
Infusion related reaction
|
7.5%
3/40 • 6 months
|
|
General disorders
Injection site reaction
|
2.5%
1/40 • 6 months
|
|
General disorders
Malaise
|
10.0%
4/40 • 6 months
|
|
General disorders
Mucosal infection
|
2.5%
1/40 • 6 months
|
|
General disorders
Non-cardiac chest pain
|
10.0%
4/40 • 6 months
|
|
General disorders
Pain
|
2.5%
1/40 • 6 months
|
|
General disorders
Pyrexia
|
10.0%
4/40 • 6 months
|
|
General disorders
Systemic inflammatory response syndrome
|
2.5%
1/40 • 6 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
5.0%
2/40 • 6 months
|
|
Hepatobiliary disorders
Hepatic cyst
|
2.5%
1/40 • 6 months
|
|
Immune system disorders
Hypersensitivity
|
10.0%
4/40 • 6 months
|
|
Immune system disorders
Psoriasis
|
2.5%
1/40 • 6 months
|
|
Immune system disorders
Rhinitis allergic
|
5.0%
2/40 • 6 months
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Folliculitis
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Furuncle
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Influenza
|
5.0%
2/40 • 6 months
|
|
Infections and infestations
Lung infection
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Nail infection
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Papilloma viral infection
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Rhinitis
|
5.0%
2/40 • 6 months
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Sinusitis
|
5.0%
2/40 • 6 months
|
|
Infections and infestations
Skin infection
|
15.0%
6/40 • 6 months
|
|
Infections and infestations
Soft tissue infection
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Trichomoniasis
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
6/40 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
5.0%
2/40 • 6 months
|
|
Infections and infestations
Vaginal infection
|
2.5%
1/40 • 6 months
|
|
Infections and infestations
Viral infection
|
12.5%
5/40 • 6 months
|
|
Injury, poisoning and procedural complications
Blister
|
2.5%
1/40 • 6 months
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
8/40 • 6 months
|
|
Injury, poisoning and procedural complications
Fracture
|
5.0%
2/40 • 6 months
|
|
Injury, poisoning and procedural complications
Iron overload
|
2.5%
1/40 • 6 months
|
|
Injury, poisoning and procedural complications
Laceration
|
2.5%
1/40 • 6 months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.0%
2/40 • 6 months
|
|
Injury, poisoning and procedural complications
Wound
|
2.5%
1/40 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
7.5%
3/40 • 6 months
|
|
Investigations
Amylase increased
|
2.5%
1/40 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
1/40 • 6 months
|
|
Investigations
Blood alkaline phosphatase increased
|
2.5%
1/40 • 6 months
|
|
Investigations
Blood bilirubin increased
|
5.0%
2/40 • 6 months
|
|
Investigations
Blood cholesterol increased
|
2.5%
1/40 • 6 months
|
|
Investigations
Blood creatine phosphokinase increased
|
2.5%
1/40 • 6 months
|
|
Investigations
Computerised tomogram
|
2.5%
1/40 • 6 months
|
|
Investigations
Ejection fraction decreased
|
2.5%
1/40 • 6 months
|
|
Investigations
Lipase increased
|
2.5%
1/40 • 6 months
|
|
Investigations
Lymphocyte count decreased
|
20.0%
8/40 • 6 months
|
|
Investigations
Neutrophil count decreased
|
30.0%
12/40 • 6 months
|
|
Investigations
Platelet count decreased
|
12.5%
5/40 • 6 months
|
|
Investigations
Weight decreased
|
12.5%
5/40 • 6 months
|
|
Investigations
Weight increased
|
15.0%
6/40 • 6 months
|
|
Investigations
White blood cell count decreased
|
22.5%
9/40 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • 6 months
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.5%
1/40 • 6 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.5%
1/40 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.5%
1/40 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.0%
2/40 • 6 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.5%
1/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
3/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.5%
1/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
2.5%
1/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.5%
7/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
4/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
2.5%
1/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Lipoma
|
2.5%
1/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
2/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.5%
7/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Nonallopathic lesions of head region, not elsewhere classified
|
2.5%
1/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
2.5%
1/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
5.0%
2/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
5/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
2.5%
1/40 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
2.5%
1/40 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cyst
|
2.5%
1/40 • 6 months
|
|
Nervous system disorders
Headache
|
27.5%
11/40 • 6 months
|
|
Nervous system disorders
Insomnia
|
2.5%
1/40 • 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.5%
1/40 • 6 months
|
|
Nervous system disorders
Tremor
|
2.5%
1/40 • 6 months
|
|
Nervous system disorders
Urinary incontinence
|
2.5%
1/40 • 6 months
|
|
Psychiatric disorders
Anxiety
|
2.5%
1/40 • 6 months
|
|
Psychiatric disorders
Depression
|
2.5%
1/40 • 6 months
|
|
Psychiatric disorders
Hallucination
|
2.5%
1/40 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • 6 months
|
|
Renal and urinary disorders
Chromaturia
|
2.5%
1/40 • 6 months
|
|
Renal and urinary disorders
Haematuria
|
5.0%
2/40 • 6 months
|
|
Renal and urinary disorders
Pollakiuria
|
7.5%
3/40 • 6 months
|
|
Renal and urinary disorders
Proteinuria
|
7.5%
3/40 • 6 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.5%
1/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.5%
1/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
6/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.5%
9/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
2/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
2/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.5%
1/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.5%
1/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.5%
1/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.5%
1/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.0%
2/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
4/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.0%
6/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
5.0%
2/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.5%
1/40 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.0%
2/40 • 6 months
|
|
Vascular disorders
Arteriosclerosis
|
2.5%
1/40 • 6 months
|
|
Vascular disorders
Haematoma
|
2.5%
1/40 • 6 months
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • 6 months
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • 6 months
|
Additional Information
Dunbar, Cynthia
National Heart Lung and Blood Institute
Phone: +1 301 827 1164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place