Trial Outcomes & Findings for Hydroxyurea and Magnesium Pidolate to Treat People With Hemoglobin Sickle Cell Disease (NCT NCT00532883)
NCT ID: NCT00532883
Last Updated: 2013-01-18
Results Overview
An individuals' percentage of red blood cells with density greater than 41 g/dL as measured by Advia.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
measured 2 months after initiation of treatment
Results posted on
2013-01-18
Participant Flow
Subjects were recruited from October 2006 through June 2008 at 10 sites across the United States. Subjects were recruited from sickle cell specific clinics.
Subjects were screened to ensure specific laboratory measurement levels after enrollment but prior to randomization.
Participant milestones
| Measure |
Hydroxyurea/Magnesium
Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
|
Hydroxyurea/Mg Placebo
Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
|
HU Placebo/Magnesium
HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
|
HU Placebo/Mg Placebo
Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
10
|
11
|
|
Overall Study
COMPLETED
|
5
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
4
|
5
|
Reasons for withdrawal
| Measure |
Hydroxyurea/Magnesium
Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
|
Hydroxyurea/Mg Placebo
Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
|
HU Placebo/Magnesium
HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
|
HU Placebo/Mg Placebo
Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Subject was Nonadherent
|
0
|
1
|
1
|
0
|
|
Overall Study
Early Study Termination
|
4
|
4
|
1
|
4
|
Baseline Characteristics
Hydroxyurea and Magnesium Pidolate to Treat People With Hemoglobin Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
Hydroxyurea/Magnesium
n=11 Participants
Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
|
Hydroxyurea/Mg Placebo
n=12 Participants
Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
|
HU Placebo/Magnesium
n=10 Participants
HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
|
HU Placebo/Mg Placebo
n=11 Participants
Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
37 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age Continuous
|
12.5 years
STANDARD_DEVIATION 4.41 • n=39 Participants
|
16.8 years
STANDARD_DEVIATION 12.6 • n=41 Participants
|
14.8 years
STANDARD_DEVIATION 8.45 • n=35 Participants
|
17.3 years
STANDARD_DEVIATION 12.41 • n=31 Participants
|
16.7 years
STANDARD_DEVIATION 9.81 • n=146 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
19 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
25 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=39 Participants
|
12 participants
n=41 Participants
|
10 participants
n=35 Participants
|
11 participants
n=31 Participants
|
44 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: measured 2 months after initiation of treatmentPopulation: ITT: All randomized subjects who receive any clinical trial material. Subjects in the ITT population will be classified according to the treatment group to which they were randomized, regardless of what study drug they received.
An individuals' percentage of red blood cells with density greater than 41 g/dL as measured by Advia.
Outcome measures
| Measure |
Hydroxyurea/Magnesium
n=11 Participants
Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
|
Hydroxyurea/Mg Placebo
n=12 Participants
Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
|
HU Placebo/Magnesium
n=10 Participants
HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
|
HU Placebo/Mg Placebo
n=11 Participants
Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
|
|---|---|---|---|---|
|
Distribution of the Density of Hemoglobin SC Red Cells
|
12.09 percent of cells
Standard Deviation 5.075
|
11.16 percent of cells
Standard Deviation 7.296
|
10.49 percent of cells
Standard Deviation 4.572
|
12.79 percent of cells
Standard Deviation 3.739
|
Adverse Events
Hydroxyurea/Magnesium Pidolate
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Hydroxyurea/Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo/Magnesium Pidolate
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo/Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydroxyurea/Magnesium Pidolate
n=11 participants at risk
20 mg/kg/day
|
Hydroxyurea/Placebo
n=12 participants at risk
0.6 mEq/kg/day
|
Placebo/Magnesium Pidolate
n=10 participants at risk
20 mg/kg/day HU + 0.6 mEq/kg/day Mg
|
Placebo/Placebo
n=11 participants at risk
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Acute chest syndrome
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Infections and infestations
Pharyngitis streptococcal
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
General disorders
Pyrexia
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
27.3%
3/11 • Number of events 5
|
8.3%
1/12 • Number of events 3
|
30.0%
3/10 • Number of events 4
|
18.2%
2/11 • Number of events 3
|
|
Surgical and medical procedures
Skin graft
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
Other adverse events
| Measure |
Hydroxyurea/Magnesium Pidolate
n=11 participants at risk
20 mg/kg/day
|
Hydroxyurea/Placebo
n=12 participants at risk
0.6 mEq/kg/day
|
Placebo/Magnesium Pidolate
n=10 participants at risk
20 mg/kg/day HU + 0.6 mEq/kg/day Mg
|
Placebo/Placebo
n=11 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
2/11 • Number of events 5
|
8.3%
1/12 • Number of events 2
|
0.00%
0/10
|
18.2%
2/11 • Number of events 3
|
|
Infections and infestations
Abscess
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Investigations
Arterial bruit
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.2%
2/11 • Number of events 2
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Eye disorders
Conjunctivitis
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
18.2%
2/11 • Number of events 5
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
2/11 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
10.0%
1/10 • Number of events 2
|
18.2%
2/11 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/11
|
16.7%
2/12 • Number of events 3
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Eye disorders
Eye pruritus
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Furuncle
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • Number of events 10
|
41.7%
5/12 • Number of events 6
|
10.0%
1/10 • Number of events 1
|
27.3%
3/11 • Number of events 4
|
|
Immune system disorders
Hypersensitivity
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
General disorders
Influenza like illness
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Infusion site erythema
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
General disorders
Injection site pain
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Limb injury
|
18.2%
2/11 • Number of events 2
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Nervous system disorders
Migraine
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Myringitis bullous
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11
|
0.00%
0/12
|
20.0%
2/10 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/10
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Eye disorders
Ocular icterus
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Oral soft tissue disorder
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Infections and infestations
Otitis media
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
General disorders
Pain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
General disorders
Pyrexia
|
18.2%
2/11 • Number of events 3
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
2/11 • Number of events 2
|
0.00%
0/12
|
20.0%
2/10 • Number of events 2
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
54.5%
6/11 • Number of events 39
|
50.0%
6/12 • Number of events 18
|
40.0%
4/10 • Number of events 7
|
72.7%
8/11 • Number of events 32
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
18.2%
2/11 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Spleen palpable
|
0.00%
0/11
|
16.7%
2/12 • Number of events 3
|
0.00%
0/10
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 2
|
18.2%
2/11 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Viral infection
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 3
|
8.3%
1/12 • Number of events 2
|
30.0%
3/10 • Number of events 4
|
27.3%
3/11 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place