Trial Outcomes & Findings for Replagal Enzyme Replacement Therapy for Children With Fabry Disease (NCT NCT00084084)
NCT ID: NCT00084084
Last Updated: 2021-07-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
362 weeks
Results posted on
2021-07-30
Participant Flow
No patient was enrolled in Cohort 2 (ie, no treatment-naive patients were enrolled).
Participant milestones
| Measure |
Agalsidase Alfa (Cohort 1)
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Phase 1 (Treatment With Replagal RB)
STARTED
|
17
|
|
Phase 1 (Treatment With Replagal RB)
COMPLETED
|
16
|
|
Phase 1 (Treatment With Replagal RB)
NOT COMPLETED
|
1
|
|
Phase 2 (Transition to Replagal AF)
STARTED
|
11
|
|
Phase 2 (Transition to Replagal AF)
COMPLETED
|
10
|
|
Phase 2 (Transition to Replagal AF)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Agalsidase Alfa (Cohort 1)
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Phase 1 (Treatment With Replagal RB)
Lost to Follow-up
|
1
|
|
Phase 2 (Transition to Replagal AF)
Failure to visit clinic as scheduled
|
1
|
Baseline Characteristics
Replagal Enzyme Replacement Therapy for Children With Fabry Disease
Baseline characteristics by cohort
| Measure |
Agalsidase Alfa (Cohort 1)
n=17 Participants
0.2 mg/kg agalsidase alfa infused by IV over 40 (+/- 10) minutes every other week
|
|---|---|
|
Age, Continuous
|
11.99 years
STANDARD_DEVIATION 3.2464 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
|
Baseline Heart Rate Variability (SDNN)
|
98.947 msec
STANDARD_DEVIATION 32.324 • n=5 Participants
|
PRIMARY outcome
Timeframe: 362 weeksPopulation: Safety Population: Patients in Cohort 1 who received at least one dose of Replagal RB in Phase 1.
Outcome measures
| Measure |
Agalsidase Alfa (Cohort 1)
n=17 Participants
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Patients Who Experienced At Least One Adverse Event (AE)
|
17 participants
|
SECONDARY outcome
Timeframe: Pre-infusion; and post-infusion at 20, 40, 50, 60, 90 minutes, and 2, 3, 4, 8 hours.Population: PK Population: All patients who received at least 1 dose of Replagal (RB or AF) and had at least 1 PK sample drawn.
AUC0-∞ is a measure of the total exposure to a drug.
Outcome measures
| Measure |
Agalsidase Alfa (Cohort 1)
n=11 Participants
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Pharmacokinetics - Area Under the Serum Concentration-Time Curve (AUC0-∞) - Week 81
|
245282 min·U/mL
Standard Deviation 159071
|
SECONDARY outcome
Timeframe: Pre-infusion; and post-infusion at 20, 40, 50, 60, 90 minutes, and 2, 3, 4, 8 hours.Population: PK Population: All patients who received at least 1 dose of Replagal (RB or AF) and had at least 1 PK sample drawn.
AUC0-∞ is a measure of the total exposure to a drug.
Outcome measures
| Measure |
Agalsidase Alfa (Cohort 1)
n=11 Participants
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Pharmacokinetics - Area Under the Serum Concentration-Time Curve (AUC0-∞) - Week 133
|
295779 min·U/mL
Standard Deviation 161058
|
SECONDARY outcome
Timeframe: Pre-infusion; and post-infusion at 20, 40, 50, 60, 90 minutes, and 2, 3, 4, 8 hours.Population: PK Population: All patients who received at least 1 dose of Replagal (RB or AF) and had at least 1 PK sample drawn.
AUC0-∞ is a measure of the total exposure to a drug.
Outcome measures
| Measure |
Agalsidase Alfa (Cohort 1)
n=11 Participants
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Pharmacokinetics - Area Under the Serum Concentration-Time Curve (AUC0-∞) - Week 159
|
218078 min·U/mL
Standard Deviation 73560
|
SECONDARY outcome
Timeframe: Pre-infusion; and post-infusion at 20, 40, 50, 60, 90 minutes, and 2, 3, 4, 8 hours.Population: PK Population: All patients who received at least 1 dose of Replagal (RB or AF) and had at least 1 PK sample drawn.
AUC0-∞ is a measure of the total exposure to a drug.
Outcome measures
| Measure |
Agalsidase Alfa (Cohort 1)
n=11 Participants
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Pharmacokinetics - Area Under the Serum Concentration-Time Curve (AUC0-∞) - Week 315/341
|
213193 min·U/mL
Standard Deviation 119581
|
SECONDARY outcome
Timeframe: Pre-infusion; and post-infusion at 20, 40, 50, 60, 90 minutes, and 2, 3, 4, 8 hours.Cmax is the peak plasma concentration of a drug after administration.
Outcome measures
| Measure |
Agalsidase Alfa (Cohort 1)
n=11 Participants
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Pharmacokinetics - Maximum Observed Serum Concentration (Cmax) - Week 81
|
3173 U/mL
Standard Deviation 969
|
SECONDARY outcome
Timeframe: Pre-infusion; and post-infusion at 20, 40, 50, 60, 90 minutes, and 2, 3, 4, 8 hours.Cmax is the peak plasma concentration of a drug after administration.
Outcome measures
| Measure |
Agalsidase Alfa (Cohort 1)
n=11 Participants
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Pharmacokinetics - Maximum Observed Serum Concentration (Cmax) - Week 133
|
3842 U/mL
Standard Deviation 1235
|
SECONDARY outcome
Timeframe: Pre-infusion; and post-infusion at 20, 40, 50, 60, 90 minutes, and 2, 3, 4, 8 hours.Cmax is the peak plasma concentration of a drug after administration.
Outcome measures
| Measure |
Agalsidase Alfa (Cohort 1)
n=11 Participants
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Pharmacokinetics - Maximum Observed Serum Concentration (Cmax) - Week 159
|
3842 U/mL
Standard Deviation 1235
|
SECONDARY outcome
Timeframe: Pre-infusion; and post-infusion at 20, 40, 50, 60, 90 minutes, and 2, 3, 4, 8 hours.Cmax is the peak plasma concentration of a drug after administration.
Outcome measures
| Measure |
Agalsidase Alfa (Cohort 1)
n=11 Participants
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Pharmacokinetics - Maximum Observed Serum Concentration (Cmax) - Week 315/341
|
3568 U/mL
Standard Deviation 1492
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 185Population: Number of participants present at Visit Week 185 included for analysis.
Heart rate variability was assessed by 2-hour Holter monitoring. Standard deviation of all filtered RR intervals over the length of the analysis (SDNN) was measured.
Outcome measures
| Measure |
Agalsidase Alfa (Cohort 1)
n=9 Participants
Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
|
|---|---|
|
Heart Rate Variability - Change From Baseline at Week 185 in SDNN
|
20.256 msec
Standard Deviation 29.060
|
Adverse Events
Safety Population RB
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Transition Safety Population
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Population RB
n=17 participants at risk
Patients in Cohort 1 who received at least 1 dose of Replagal RB in Phase 1 - no data from Phase 2 (Replagal AF) included.
|
Transition Safety Population
n=11 participants at risk
A subset of patients from the Safety Population RB who additionally received at least 1 dose of Replagal AF in Phase 2.
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
Nervous system disorders
Neuralgia
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
Nervous system disorders
Cerebrovascular Accident
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Ear and labyrinth disorders
Vertigo Positional
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Renal Injury
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Traumatic Liver Injury
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Congenital, familial and genetic disorders
Pectus Excavatum
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
Other adverse events
| Measure |
Safety Population RB
n=17 participants at risk
Patients in Cohort 1 who received at least 1 dose of Replagal RB in Phase 1 - no data from Phase 2 (Replagal AF) included.
|
Transition Safety Population
n=11 participants at risk
A subset of patients from the Safety Population RB who additionally received at least 1 dose of Replagal AF in Phase 2.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis Viral
|
47.1%
8/17 • Number of events 12 • 362 weeks
|
45.5%
5/11 • Number of events 6 • 362 weeks
|
|
Infections and infestations
Nasopharyngitis
|
41.2%
7/17 • Number of events 12 • 362 weeks
|
54.5%
6/11 • Number of events 12 • 362 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
23.5%
4/17 • Number of events 11 • 362 weeks
|
45.5%
5/11 • Number of events 16 • 362 weeks
|
|
Infections and infestations
Influenza
|
17.6%
3/17 • Number of events 3 • 362 weeks
|
27.3%
3/11 • Number of events 3 • 362 weeks
|
|
Infections and infestations
Bronchitis
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
Infections and infestations
Ear Infection
|
11.8%
2/17 • Number of events 3 • 362 weeks
|
18.2%
2/11 • Number of events 3 • 362 weeks
|
|
Infections and infestations
Sinusitis
|
11.8%
2/17 • Number of events 5 • 362 weeks
|
36.4%
4/11 • Number of events 8 • 362 weeks
|
|
Infections and infestations
Acarodermatitis
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Infections and infestations
Hordeolum
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Impetigo
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Infected Bites
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Infectious Mononucleosis
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Lung Infection
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Otitis Media
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Pharyngitis Streptococcal
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Rocky Mountain Spotted Fever
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Tinea Pedis
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Viral Infection
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
27.3%
3/11 • Number of events 3 • 362 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Infections and infestations
Abscess
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Blister Infected
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Body Tinea
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Localised Infection
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Molluscum Contagiosum
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Infections and infestations
Tonsillitis
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Immune system disorders
Drug Hypersensitivity
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
17.6%
3/17 • Number of events 3 • 362 weeks
|
27.3%
3/11 • Number of events 3 • 362 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Metabolism and nutrition disorders
Obesity
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Psychiatric disorders
Attention Deficit / Hyperactivity Disorder
|
17.6%
3/17 • Number of events 4 • 362 weeks
|
18.2%
2/11 • Number of events 3 • 362 weeks
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Psychiatric disorders
Decreased Activity
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 3 • 362 weeks
|
|
Psychiatric disorders
Panic Disorder
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Psychiatric disorders
Agitation
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Headache
|
52.9%
9/17 • Number of events 33 • 362 weeks
|
63.6%
7/11 • Number of events 46 • 362 weeks
|
|
Nervous system disorders
Neuralgia
|
52.9%
9/17 • Number of events 35 • 362 weeks
|
63.6%
7/11 • Number of events 32 • 362 weeks
|
|
Nervous system disorders
Burning Sensation
|
35.3%
6/17 • Number of events 16 • 362 weeks
|
45.5%
5/11 • Number of events 15 • 362 weeks
|
|
Nervous system disorders
Paraesthesia
|
17.6%
3/17 • Number of events 7 • 362 weeks
|
27.3%
3/11 • Number of events 7 • 362 weeks
|
|
Nervous system disorders
Balance Disorder
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 3 • 362 weeks
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Nervous system disorders
Amnesia
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Cerebral Infarction
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Cerebrovascular Accident
|
5.9%
1/17 • Number of events 5 • 362 weeks
|
9.1%
1/11 • Number of events 5 • 362 weeks
|
|
Nervous system disorders
Coordination Abnormal
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Cranial Nerve Disorder
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Dysarthria
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Facial Paresis
|
5.9%
1/17 • Number of events 3 • 362 weeks
|
9.1%
1/11 • Number of events 3 • 362 weeks
|
|
Nervous system disorders
Hypersomnia
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Migraine
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Poor Quality Sleep
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Presyncope
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Reflexes Abnormal
|
5.9%
1/17 • Number of events 3 • 362 weeks
|
9.1%
1/11 • Number of events 3 • 362 weeks
|
|
Nervous system disorders
Sinus Headache
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Thalamic Infarction
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Nervous system disorders
Disturbance in Attention
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
Eye disorders
Diplopia
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Eye disorders
Eye Pain
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Eye disorders
Eye Swelling
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Eye disorders
Gaze Palsy
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Eye disorders
Myopia
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Eye disorders
Strabismus
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Eye disorders
Refraction Disorder
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Ear and labyrinth disorders
Ear Pain
|
23.5%
4/17 • Number of events 6 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Ear and labyrinth disorders
Deafness Unilateral
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Ear and labyrinth disorders
Middle Ear Effusion
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Ear and labyrinth disorders
Otorrhoea
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Ear and labyrinth disorders
Tympanic Membrane Perforation
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Ear and labyrinth disorders
Vertigo Positional
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Cardiac disorders
Arrhythmia Supraventricular
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
Cardiac disorders
Palpitations
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Cardiac disorders
Sinus Tachycardia
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Cardiac disorders
Tachycardia
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
18.2%
2/11 • Number of events 3 • 362 weeks
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Vascular disorders
Flushing
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 6 • 362 weeks
|
|
Vascular disorders
Haematoma
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Vascular disorders
Haemorrhage
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Vascular disorders
Pallor
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
76.5%
13/17 • Number of events 27 • 362 weeks
|
90.9%
10/11 • Number of events 23 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
58.8%
10/17 • Number of events 16 • 362 weeks
|
54.5%
6/11 • Number of events 14 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
29.4%
5/17 • Number of events 8 • 362 weeks
|
45.5%
5/11 • Number of events 14 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
23.5%
4/17 • Number of events 5 • 362 weeks
|
36.4%
4/11 • Number of events 5 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.6%
3/17 • Number of events 4 • 362 weeks
|
54.5%
6/11 • Number of events 10 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
17.6%
3/17 • Number of events 4 • 362 weeks
|
27.3%
3/11 • Number of events 4 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 4 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
47.1%
8/17 • Number of events 13 • 362 weeks
|
72.7%
8/11 • Number of events 14 • 362 weeks
|
|
Gastrointestinal disorders
Nausea
|
41.2%
7/17 • Number of events 11 • 362 weeks
|
45.5%
5/11 • Number of events 15 • 362 weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
35.3%
6/17 • Number of events 10 • 362 weeks
|
54.5%
6/11 • Number of events 12 • 362 weeks
|
|
Gastrointestinal disorders
Vomiting
|
35.3%
6/17 • Number of events 13 • 362 weeks
|
54.5%
6/11 • Number of events 12 • 362 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
4/17 • Number of events 11 • 362 weeks
|
54.5%
6/11 • Number of events 17 • 362 weeks
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
27.3%
3/11 • Number of events 3 • 362 weeks
|
|
Gastrointestinal disorders
Toothache
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Gastrointestinal disorders
Dental Caries
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
Gastrointestinal disorders
Faecal Incontinence
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Gastrointestinal disorders
Lip Swelling
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 3 • 362 weeks
|
|
Gastrointestinal disorders
Retching
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
17.6%
3/17 • Number of events 5 • 362 weeks
|
27.3%
3/11 • Number of events 6 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
17.6%
3/17 • Number of events 5 • 362 weeks
|
27.3%
3/11 • Number of events 5 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Angiokeratoma
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
27.3%
3/11 • Number of events 4 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.9%
1/17 • Number of events 3 • 362 weeks
|
9.1%
1/11 • Number of events 3 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 3 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Number of events 3 • 362 weeks
|
27.3%
3/11 • Number of events 5 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
1/17 • Number of events 5 • 362 weeks
|
9.1%
1/11 • Number of events 6 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Vasculitic Rash
|
5.9%
1/17 • Number of events 3 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
47.1%
8/17 • Number of events 9 • 362 weeks
|
45.5%
5/11 • Number of events 9 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
47.1%
8/17 • Number of events 59 • 362 weeks
|
72.7%
8/11 • Number of events 67 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.8%
2/17 • Number of events 6 • 362 weeks
|
18.2%
2/11 • Number of events 9 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
11.8%
2/17 • Number of events 3 • 362 weeks
|
27.3%
3/11 • Number of events 4 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
11.8%
2/17 • Number of events 3 • 362 weeks
|
18.2%
2/11 • Number of events 4 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Posture Abnormal
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Renal and urinary disorders
Dysuria
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Renal and urinary disorders
Urethral Meatus Stenosis
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Renal and urinary disorders
Haematuria
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Reproductive system and breast disorders
Testicular Pain
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Reproductive system and breast disorders
Balanitis
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Reproductive system and breast disorders
Scrotal Pain
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Reproductive system and breast disorders
Testicular Oedema
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Congenital, familial and genetic disorders
Pectus Excavatum
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
General disorders
Pyrexia
|
70.6%
12/17 • Number of events 27 • 362 weeks
|
81.8%
9/11 • Number of events 19 • 362 weeks
|
|
General disorders
Chest Pain
|
35.3%
6/17 • Number of events 9 • 362 weeks
|
63.6%
7/11 • Number of events 13 • 362 weeks
|
|
General disorders
Fatigue
|
23.5%
4/17 • Number of events 5 • 362 weeks
|
36.4%
4/11 • Number of events 6 • 362 weeks
|
|
General disorders
Pain
|
17.6%
3/17 • Number of events 5 • 362 weeks
|
36.4%
4/11 • Number of events 8 • 362 weeks
|
|
General disorders
Gait Disturbance
|
11.8%
2/17 • Number of events 3 • 362 weeks
|
18.2%
2/11 • Number of events 4 • 362 weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
45.5%
5/11 • Number of events 7 • 362 weeks
|
|
General disorders
Oedema Peripheral
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
18.2%
2/11 • Number of events 3 • 362 weeks
|
|
General disorders
Asthenia
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
General disorders
Chest Discomfort
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
General disorders
Chills
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
General disorders
Infusion Site Pain
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
General disorders
Irritability
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
General disorders
Temperature Intolerance
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
General disorders
Influenza Like Illness
|
0.00%
0/17 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Investigations
Albumin Urine Present
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
Investigations
Blood Albumin Increased
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Investigations
Blood Pressure Increased
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Investigations
Blood Triglycerides Increased
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Investigations
C-Reactive Protein Increased
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Investigations
Nuclear Magnetic Resonance Imaging Brain Abnormal
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Investigations
Pulmonary Function Test Decreased
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Investigations
Sputum Abnormal
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Investigations
Weight Decreased
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
29.4%
5/17 • Number of events 15 • 362 weeks
|
45.5%
5/11 • Number of events 16 • 362 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
29.4%
5/17 • Number of events 16 • 362 weeks
|
45.5%
5/11 • Number of events 16 • 362 weeks
|
|
Injury, poisoning and procedural complications
Post-Traumatic Pain
|
23.5%
4/17 • Number of events 5 • 362 weeks
|
36.4%
4/11 • Number of events 5 • 362 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
17.6%
3/17 • Number of events 8 • 362 weeks
|
27.3%
3/11 • Number of events 8 • 362 weeks
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
17.6%
3/17 • Number of events 9 • 362 weeks
|
27.3%
3/11 • Number of events 10 • 362 weeks
|
|
Injury, poisoning and procedural complications
Joint Injury
|
11.8%
2/17 • Number of events 3 • 362 weeks
|
18.2%
2/11 • Number of events 3 • 362 weeks
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Limb Injury
|
11.8%
2/17 • Number of events 4 • 362 weeks
|
18.2%
2/11 • Number of events 4 • 362 weeks
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
11.8%
2/17 • Number of events 2 • 362 weeks
|
36.4%
4/11 • Number of events 4 • 362 weeks
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 3 • 362 weeks
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Head Injury
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Heat Exhaustion
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
0.00%
0/11 • 362 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Renal Injury
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Scratch
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
18.2%
2/11 • Number of events 2 • 362 weeks
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
5.9%
1/17 • Number of events 2 • 362 weeks
|
9.1%
1/11 • Number of events 2 • 362 weeks
|
|
Injury, poisoning and procedural complications
Traumatic Liver Injury
|
5.9%
1/17 • Number of events 1 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
|
Injury, poisoning and procedural complications
Neck Injury
|
0.00%
0/17 • 362 weeks
|
9.1%
1/11 • Number of events 1 • 362 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Shire's agreements with investigators vary. All agreements provide Shire the right to embargo communications regarding trial results prior to public release for a period ≤ 180 days from the time submitted to Shire for review. Shire does not prohibit publication but can require the removal of confidential information (excluding trial results) and can request postponement of a single-center publication until after disclosure of the trial's multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER