Trial Outcomes & Findings for CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis (NCT NCT02629419)
NCT ID: NCT02629419
Last Updated: 2024-08-07
Results Overview
Number of subjects with a clinical response of clinical cure or improvement. Clinical cure was defined as absence of signs or symptoms of infection. Clinical improvement was defined as follows: * OPC or EC: partial resolution defined as greater than or equal to 50% of Baseline signs or symptoms * VVC: reduction of greater than or equal to 50% of clinical severity score from Baseline Severity of each symptom was graded on a scale from zero (absence of symptoms) to 3 (severe symptoms). The sum of all scores for all symptoms was used as the clinical severity score. Higher scores mean worse outcomes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
14-days at highest titrated dose
Results posted on
2024-08-07
Participant Flow
Participant milestones
| Measure |
MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB])
MAT2203 (200 mg, 400 mg, 800 mg)
Oral lipid nanocrystal formulation of amphotericin B
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis
Baseline characteristics by cohort
| Measure |
MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB])
n=4 Participants
MAT2203 (200 mg, 400 mg, 800 mg)
Oral lipid nanocrystal formulation of amphotericin B
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
|
Chronic Mucocutaneous Candidiasis (CMC) Infection Type
Oropharyngeal candidiasis (OPC)
|
3 participants
n=5 Participants
|
|
Chronic Mucocutaneous Candidiasis (CMC) Infection Type
Esophageal candidiasis (EC)
|
1 participants
n=5 Participants
|
|
Chronic Mucocutaneous Candidiasis (CMC) Infection Type
Vulvovaginal candidiasis (VVC)
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14-days at highest titrated doseNumber of subjects with a clinical response of clinical cure or improvement. Clinical cure was defined as absence of signs or symptoms of infection. Clinical improvement was defined as follows: * OPC or EC: partial resolution defined as greater than or equal to 50% of Baseline signs or symptoms * VVC: reduction of greater than or equal to 50% of clinical severity score from Baseline Severity of each symptom was graded on a scale from zero (absence of symptoms) to 3 (severe symptoms). The sum of all scores for all symptoms was used as the clinical severity score. Higher scores mean worse outcomes.
Outcome measures
| Measure |
MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB])
n=4 Participants
MAT2203 (200 mg, 400 mg, 800 mg)
Oral lipid nanocrystal formulation of amphotericin B
|
|---|---|
|
Clinical Response to Treatment of Mucocutaneous Candidiasis
|
4 Participants
|
SECONDARY outcome
Timeframe: Single and Multiple Doses (14-days)Population: 2 participants were not included in the analysis
Drug concentration in plasma collected at 0, 1, 2, 4, 8, 10, 12, and 24 hours post-dose
Outcome measures
| Measure |
MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB])
n=2 Participants
MAT2203 (200 mg, 400 mg, 800 mg)
Oral lipid nanocrystal formulation of amphotericin B
|
|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Postdose
|
606 ng x h/mL
Interval 435.18 to 777.17
|
SECONDARY outcome
Timeframe: Single and Multiple Doses (14-days)Plasma concentration was measured at 0, 1, 2, 4, 8, 10, 12, and 24 hours post-dose
Outcome measures
| Measure |
MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB])
n=4 Participants
MAT2203 (200 mg, 400 mg, 800 mg)
Oral lipid nanocrystal formulation of amphotericin B
|
|---|---|
|
Maximum Plasma Concentration (Cmax)
|
28.4 ng/mL
Interval 27.02 to 52.6
|
SECONDARY outcome
Timeframe: Single and Multiple Doses (14-days)Plasma collected at 0, 1, 2, 4, 8, 10, 12, and 24 hours post-dose
Outcome measures
| Measure |
MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB])
n=4 Participants
MAT2203 (200 mg, 400 mg, 800 mg)
Oral lipid nanocrystal formulation of amphotericin B
|
|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
|
16 h
Interval 4.0 to 24.0
|
SECONDARY outcome
Timeframe: up to 60 monthsIncidence of nephrotoxicity, defined as an increase of greater than 100% of baseline serum creatinine. Incidence of hypokalemia, defined as serum potassium less than or equal to 3mmol/L during or within 3 weeks of completing treatment.
Outcome measures
| Measure |
MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB])
n=4 Participants
MAT2203 (200 mg, 400 mg, 800 mg)
Oral lipid nanocrystal formulation of amphotericin B
|
|---|---|
|
Long-term Adverse Events, Changes in Laboratory Parameters
|
0 events
|
Adverse Events
MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB])
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB])
n=4 participants at risk
MAT2203 (200 mg, 400 mg, 800 mg)
Oral lipid nanocrystal formulation of amphotericin B
|
|---|---|
|
Surgical and medical procedures
Colostomy closure
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Pneumonia
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
General disorders
Influenza
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Endocrine disorders
Adrenal insufficiency
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Oral candidiasis
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Subcutaneous abscess
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
Other adverse events
| Measure |
MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB])
n=4 participants at risk
MAT2203 (200 mg, 400 mg, 800 mg)
Oral lipid nanocrystal formulation of amphotericin B
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Ear and labyrinth disorders
Tinnutis
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Ear and labyrinth disorders
Vertigo
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Eye disorders
Keratitus
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
General disorders
Hiatus Hernia
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
General disorders
Chest discomfort
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
General disorders
Chest pain
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
General disorders
Chills
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
General disorders
Fatigue
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
General disorders
Malaise
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Acute sinusitis
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Clostridium defficile infection
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Diverticulitis
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Fungal infection
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Herpes simplex
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Laryngitis
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Mucocutaneous candidiasis
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Rhinitis
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Vulvitis
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Vulvovaginal candidiasis
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Infections and infestations
Pneumonia
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Injury, poisoning and procedural complications
Fracture
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Injury, poisoning and procedural complications
Injury
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Blood albumin decreased
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Blood bicarbonate abnormal
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Blood bicarbonate decreased
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Blood cholesterol increased
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Blood immunoglobulin E increased
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Blood immunoglobulin G increased
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Blood iron decreased
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Blood lactate dehydrogenase
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Blood potassium decreased
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Blood thyroid stimulating hormone increased
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Body temperature increased
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
C-reactive protein increased
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Haemoglobin decreased
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
Oxygen saturation abnnormal
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Investigations
White blood cell count increased
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
100.0%
4/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Musculoskeletal and connective tissue disorders
Musculoskelatal chest pain
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Nervous system disorders
Aegusia
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Nervous system disorders
Cognitive disorder
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Nervous system disorders
Headache
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Renal and urinary disorders
Bladder irritation
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Renal and urinary disorders
Haematuria
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Reproductive system and breast disorders
Vaginal discharge
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Reproductive system and breast disorders
Vulvovaginal pruritis
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
4/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
50.0%
2/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Skin and subcutaneous tissue disorders
Rash
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
75.0%
3/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Surgical and medical procedures
Tooth extraction
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
|
Vascular disorders
Haematoma
|
25.0%
1/4 • Adverse events were collected over the entire study period up to 60 months
Adverse events were noted at each study visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place