Trial Outcomes & Findings for Extension Study of PRX-102 for up to 60 Months (NCT NCT01981720)
NCT ID: NCT01981720
Last Updated: 2023-09-13
Results Overview
Results represent the number of treatment-emergent adverse events (TEAE) that were considered definitely, probably or possibly related to study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Every two weeks up to 60 months
Results posted on
2023-09-13
Participant Flow
Adult Fabry disease patients who have successfully completed treatment with PRX-102 in previous studies PB-102-F01 and PB-102-F02
A total of 15 adult patients (8 male and 7 female) who completed study PB-102-F02 were enrolled in this study and included in both the Safety and Efficacy populations.
Participant milestones
| Measure |
PRX-102 (Pegunigalsidase Alfa)
PRX-102 (pegunigalsidase alfa) 1.0 mg/kg IV every 2 weeks (+/- 3 days)
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
PRX-102 (Pegunigalsidase Alfa)
PRX-102 (pegunigalsidase alfa) 1.0 mg/kg IV every 2 weeks (+/- 3 days)
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Pregnancy
|
1
|
Baseline Characteristics
Extension Study of PRX-102 for up to 60 Months
Baseline characteristics by cohort
| Measure |
PRX-102 (Pegunigalsidase Alfa)
n=15 Participants
PRX-102 (pegunigalsidase alfa) 1.0 mg/kg IV every 2 weeks (+/- 3 days)
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Paraguay
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every two weeks up to 60 monthsPopulation: Safety population is defined as all patients who received any dose (partial or complete) of study treatment as part of study PB-102-F03. Efficacy population is defined as all patients who received at least one complete dose of the study treatment as part of study PB-102-F03
Results represent the number of treatment-emergent adverse events (TEAE) that were considered definitely, probably or possibly related to study treatment.
Outcome measures
| Measure |
PRX-102 (Pegunigalsidase Alfa)
n=15 Participants
PRX-102 (pegunigalsidase alfa) 1.0 mg/kg IV every 2 weeks (+/- 3 days)
|
Male
Subject analysis set
|
Female
Subject analysis set
|
|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Safety Analysis Set : At lease 1 TEAE
|
13 participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Safety Analysis Set : At least 1 mild or moderate TEAE
|
13 participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Safety Analysis Set : At least 1 severe TEAE
|
5 participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Safety Analysis Set : At least 1 SAE
|
2 participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Safety Analysis Set : At least 1 definitely, probably or possibly related
|
4 participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Safety Analysis Set : At least 1 TEAE leading to discontinuation
|
1 participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Safety Analysis Set : At least 1 TEAE leading to death
|
1 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 60Globotriaosylsphingosine (Lyso-Gb3) is Fabry disease specific biomarker, which was measured at Baseline, every 3 months up to 24 months and then every 6 months up to the end of the study. Baseline and Month 60 and change from Baseline reported.
Outcome measures
| Measure |
PRX-102 (Pegunigalsidase Alfa)
n=15 Participants
PRX-102 (pegunigalsidase alfa) 1.0 mg/kg IV every 2 weeks (+/- 3 days)
|
Male
n=8 Participants
Subject analysis set
|
Female
n=7 Participants
Subject analysis set
|
|---|---|---|---|
|
Plasma Lyso-Gb3 Concentration
Baseline
|
70.8 ng/mL
Standard Error 20.4
|
124.4 ng/mL
Standard Error 25.9
|
9.6 ng/mL
Standard Error 2.1
|
|
Plasma Lyso-Gb3 Concentration
Month 60
|
6.4 ng/mL
Standard Error 1.5
|
9.2 ng/mL
Standard Error 1.6
|
2.1 ng/mL
Standard Error 0.9
|
|
Plasma Lyso-Gb3 Concentration
Change from Baseline to Month 60
|
-68.4 ng/mL
Standard Error 25
|
-111.0 ng/mL
Standard Error 31
|
-4.6 ng/mL
Standard Error 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 60eGFR was calculated based on the serum creatinine values according to the CKD-EPI equation. The absolute change in eGFR from baseline measurement at visit 1 to Month 60 was summarized using descriptive statistics. Baseline and month 60 reported.
Outcome measures
| Measure |
PRX-102 (Pegunigalsidase Alfa)
n=15 Participants
PRX-102 (pegunigalsidase alfa) 1.0 mg/kg IV every 2 weeks (+/- 3 days)
|
Male
n=8 Participants
Subject analysis set
|
Female
n=7 Participants
Subject analysis set
|
|---|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR)
Baseline
|
111.7 ml/min/1.73 m^2
Standard Error 5.5
|
118.1 ml/min/1.73 m^2
Standard Error 7.7
|
104.45 ml/min/1.73 m^2
Standard Error 7.5
|
|
Estimated Glomerular Filtration Rate (eGFR)
Month 60
|
97.0 ml/min/1.73 m^2
Standard Error 6.4
|
100.0 ml/min/1.73 m^2
Standard Error 8.3
|
92.4 ml/min/1.73 m^2
Standard Error 11.4
|
|
Estimated Glomerular Filtration Rate (eGFR)
Change from Baseline to Month 60
|
-10.9 ml/min/1.73 m^2
Standard Error 2.0
|
-14.5 ml/min/1.73 m^2
Standard Error 1.7
|
-5.6 ml/min/1.73 m^2
Standard Error 2.6
|
Adverse Events
PRX-102 (Pegunigalsidase Alfa)
Serious events: 3 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PRX-102 (Pegunigalsidase Alfa)
n=15 participants at risk
PRX-102 (pegunigalsidase alfa) 1.0 mg/kg IV every 2 weeks (+/- 3 days)
|
|---|---|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
Other adverse events
| Measure |
PRX-102 (Pegunigalsidase Alfa)
n=15 participants at risk
PRX-102 (pegunigalsidase alfa) 1.0 mg/kg IV every 2 weeks (+/- 3 days)
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Immune system disorders
Drug hypersensitivity
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Immune system disorders
Seasonal allergy
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
General disorders
Chest pain
|
20.0%
3/15 • Number of events 3 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
General disorders
Fatigue
|
20.0%
3/15 • Number of events 3 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
General disorders
Pyrexia
|
13.3%
2/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
General disorders
Asthenia
|
6.7%
1/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
General disorders
Feeling hot
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
General disorders
Infusion site bruising
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
General disorders
Injection site pain
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
General disorders
Oedema
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
General disorders
Peripheral swelling
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Reproductive system and breast disorders
Breast tenderness
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Reproductive system and breast disorders
Pruritis genital
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Injury, poisoning and procedural complications
Animal bite
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Injury, poisoning and procedural complications
Sunburn
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
1/15 • Number of events 3 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Investigations
Cardiac murmur
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Investigations
Abnormal chest x-ray
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Investigations
Electrocardiogram ST segment abnormal
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Investigations
Electrocardiogram ST segment depression
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Investigations
Nuclear magnetic resonance imaging abnormal
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Cardiac disorders
Left ventricular dysfunction
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Cardiac disorders
Left ventricular hypertrophy
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Cardiac disorders
Sinus arrythmia
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • Number of events 3 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Cardiac disorders
Tricuspid valve incompetence
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Cardiac disorders
Ventricular hypertrophy
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Congenital, familial and genetic disorders
Fabry's disease
|
6.7%
1/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
5/15 • Number of events 6 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.3%
2/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
13.3%
2/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
6.7%
1/15 • Number of events 4 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Number of events 12 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Nervous system disorders
Paraesthesia
|
26.7%
4/15 • Number of events 6 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Number of events 3 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Nervous system disorders
Balance disorder
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Nervous system disorders
Burning sensation
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Nervous system disorders
Migraine
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Nervous system disorders
Neuralgia
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Nervous system disorders
Visual field defect
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Eye disorders
Conjunctival haemorrhage
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Ear and labyrinth disorders
Ear pain
|
13.3%
2/15 • Number of events 3 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Ear and labyrinth disorders
Vertigo
|
13.3%
2/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Ear and labyrinth disorders
Deafness bilateral
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Ear and labyrinth disorders
Ear discomfort
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Ear and labyrinth disorders
Hypoacusis
|
6.7%
1/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
26.7%
4/15 • Number of events 9 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
26.7%
4/15 • Number of events 9 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
4/15 • Number of events 9 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Gastrointestinal disorders
Inguinal hernia
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Gastrointestinal disorders
Tooth disorder
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Renal and urinary disorders
Dysuria
|
13.3%
2/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
3/15 • Number of events 3 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
13.3%
2/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
3/15 • Number of events 4 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
3/15 • Number of events 3 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
3/15 • Number of events 4 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.3%
2/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.7%
1/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
5/15 • Number of events 8 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Upper respiratory tract infections
|
33.3%
5/15 • Number of events 8 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Influenza
|
20.0%
3/15 • Number of events 4 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Gastroenteritis viral
|
13.3%
2/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Number of events 3 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Herpes virus infection
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Lower respiratory tract infection
|
6.7%
1/15 • Number of events 3 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Onychomycosis
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Pharyngitis
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
1/15 • Number of events 3 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Subcutaneous abscess
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Tooth infection
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Viral infection
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.7%
1/15 • Number of events 5 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
13.3%
2/15 • Number of events 2 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.7%
1/15 • Number of events 1 • The adverse events were collected during the period from PB-102-F03 baseline up to the end of study PB-102-F03 (up to 60 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The clinical trial agreement provided to the sites and Investigators contains a Publication paragraph that indicates the following: shall not, without the Sponsor's prior written consent, independently publish, present or otherwise disclose any results of or information pertaining to the trial until a multicenter publication is published, subject to certain limitations regarding timing and the confidentiality of unpublished data.
- Publication restrictions are in place
Restriction type: OTHER