Trial Outcomes & Findings for Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial (NCT NCT00705939)
NCT ID: NCT00705939
Last Updated: 2018-10-04
Results Overview
Spleen volume measured by MRI
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
45 participants
Primary outcome timeframe
Spleen Volume at Baseline and Months 12, 24, and 36
Results posted on
2018-10-04
Participant Flow
Patients completing Studies PB-06-001 (NCT00376168) or PB-06-002 (NCT00712348) were offered continued treatment in this study.
Participant milestones
| Measure |
Naive 30 Units/kg
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
|
Naive 60 Units/kg
Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
|
Switchover
Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
18
|
|
Overall Study
COMPLETED
|
12
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
4
|
Reasons for withdrawal
| Measure |
Naive 30 Units/kg
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
|
Naive 60 Units/kg
Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
|
Switchover
Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial
Baseline characteristics by cohort
| Measure |
Naive 30 Units/kg
n=12 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
|
Naive 60 Units/kg
n=14 Participants
Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
|
Switchover
n=18 Participants
Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 11.8 • n=93 Participants
|
36.6 years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
46.5 years
STANDARD_DEVIATION 13.7 • n=27 Participants
|
41.6 years
STANDARD_DEVIATION 13.0 • n=483 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
6 participants
n=27 Participants
|
6 participants
n=483 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
3 participants
n=483 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
3 participants
n=483 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
1 participants
n=483 Participants
|
|
Region of Enrollment
Chile
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
2 participants
n=483 Participants
|
|
Region of Enrollment
South Africa
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
2 participants
n=483 Participants
|
|
Region of Enrollment
Israel
|
3 participants
n=93 Participants
|
4 participants
n=4 Participants
|
6 participants
n=27 Participants
|
13 participants
n=483 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
2 participants
n=483 Participants
|
|
Region of Enrollment
Serbia
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
6 participants
n=483 Participants
|
|
Region of Enrollment
Mexico
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
0 participants
n=27 Participants
|
5 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Spleen Volume at Baseline and Months 12, 24, and 36Population: Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.
Spleen volume measured by MRI
Outcome measures
| Measure |
Switchover
n=15 Participants
Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
|
Naive 30 Units/kg
n=12 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
|
Naive 60 Units/kg
n=14 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
|
|---|---|---|---|
|
Spleen Volume
Baseline
|
778.0 mL
Standard Deviation 666.3
|
2324.0 mL
Standard Deviation 1209.0
|
2120.0 mL
Standard Deviation 1426.5
|
|
Spleen Volume
Month 12
|
883.7 mL
Standard Deviation 760.0
|
1707.7 mL
Standard Deviation 1069.5
|
1267.9 mL
Standard Deviation 1114.1
|
|
Spleen Volume
Month 24
|
609.1 mL
Standard Deviation 442.7
|
1420.4 mL
Standard Deviation 852.3
|
946.7 mL
Standard Deviation 699.6
|
|
Spleen Volume
Month 36
|
548.2 mL
Standard Deviation 433.7
|
1237.2 mL
Standard Deviation 695.7
|
761.0 mL
Standard Deviation 556.0
|
SECONDARY outcome
Timeframe: Liver volume at Baseline and Months 12, 24 and 36Population: Intent to treat. In the Switchover group, two patients did not have MRI .
Liver volume measured by MRI
Outcome measures
| Measure |
Switchover
n=16 Participants
Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
|
Naive 30 Units/kg
n=12 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
|
Naive 60 Units/kg
n=14 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
|
|---|---|---|---|
|
Liver Volume
Baseline
|
1775.7 mL
Standard Deviation 434.4
|
2999.7 mL
Standard Deviation 779.4
|
2470.5 mL
Standard Deviation 484.9
|
|
Liver Volume
Month 12
|
1788.9 mL
Standard Deviation 378.0
|
2515.6 mL
Standard Deviation 642.1
|
2118.7 mL
Standard Deviation 318.1
|
|
Liver Volume
Month 24
|
1757.1 mL
Standard Deviation 357.0
|
2362.8 mL
Standard Deviation 518.7
|
1998.2 mL
Standard Deviation 291.9
|
|
Liver Volume
Month 36
|
1821.2 mL
Standard Deviation 523.6
|
2341.1 mL
Standard Deviation 553.4
|
1971.8 mL
Standard Deviation 404.7
|
SECONDARY outcome
Timeframe: Hemoglobin at Baseline and Months 12, 24 and 36Outcome measures
| Measure |
Switchover
n=18 Participants
Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
|
Naive 30 Units/kg
n=12 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
|
Naive 60 Units/kg
n=14 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
|
|---|---|---|---|
|
Hemoglobin
Baseline
|
13.6 mg/dL
Standard Deviation 1.6
|
12.5 mg/dL
Standard Deviation 1.8
|
11.4 mg/dL
Standard Deviation 2.7
|
|
Hemoglobin
Month 12
|
13.6 mg/dL
Standard Deviation 1.7
|
14.2 mg/dL
Standard Deviation 1.7
|
13.6 mg/dL
Standard Deviation 2.6
|
|
Hemoglobin
Month 24
|
13.5 mg/dL
Standard Deviation 1.2
|
13.8 mg/dL
Standard Deviation 1.6
|
13.8 mg/dL
Standard Deviation 1.8
|
|
Hemoglobin
Month 36
|
13.3 mg/dL
Standard Deviation 1.2
|
14.3 mg/dL
Standard Deviation 1.5
|
14.1 mg/dL
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Platelet count at Baseline and Months 12, 24 and 36Outcome measures
| Measure |
Switchover
n=18 Participants
Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
|
Naive 30 Units/kg
n=12 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
|
Naive 60 Units/kg
n=14 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
|
|---|---|---|---|
|
Platelet Count
Baseline
|
163833 Platelets per cubic millimeter
Standard Deviation 88882
|
64900 Platelets per cubic millimeter
Standard Deviation 30133
|
69043 Platelets per cubic millimeter
Standard Deviation 28242
|
|
Platelet Count
Month 12
|
145250 Platelets per cubic millimeter
Standard Deviation 97426
|
80325 Platelets per cubic millimeter
Standard Deviation 41806
|
122857 Platelets per cubic millimeter
Standard Deviation 53857
|
|
Platelet Count
Month 24
|
174200 Platelets per cubic millimeter
Standard Deviation 100483
|
93333 Platelets per cubic millimeter
Standard Deviation 53328
|
141071 Platelets per cubic millimeter
Standard Deviation 73896
|
|
Platelet Count
Month 36
|
172467 Platelets per cubic millimeter
Standard Deviation 89340
|
94683 Platelets per cubic millimeter
Standard Deviation 47526
|
144417 Platelets per cubic millimeter
Standard Deviation 55190
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Months 12, 24, and 36Population: Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.
Spleen volume measured by MRI. Normal spleen volume is 2 mL/kg × body weight (kg)
Outcome measures
| Measure |
Switchover
n=15 Participants
Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
|
Naive 30 Units/kg
n=12 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
|
Naive 60 Units/kg
n=14 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
|
|---|---|---|---|
|
Spleen Volume Multiples of Normal (MN)
Month 24
|
4.0 Multiples of Normal Spleen Volume
Standard Deviation 2.7
|
9.6 Multiples of Normal Spleen Volume
Standard Deviation 1.6
|
6.6 Multiples of Normal Spleen Volume
Standard Deviation 5.3
|
|
Spleen Volume Multiples of Normal (MN)
Month 36
|
3.7 Multiples of Normal Spleen Volume
Standard Deviation 2.9
|
8.2 Multiples of Normal Spleen Volume
Standard Deviation 4.4
|
5.6 Multiples of Normal Spleen Volume
Standard Deviation 4.5
|
|
Spleen Volume Multiples of Normal (MN)
Baseline
|
5.5 Multiples of Normal Spleen Volume
Standard Deviation 5.4
|
16.4 Multiples of Normal Spleen Volume
Standard Deviation 8.3
|
16.8 Multiples of Normal Spleen Volume
Standard Deviation 14.2
|
|
Spleen Volume Multiples of Normal (MN)
Month 12
|
7.0 Multiples of Normal Spleen Volume
Standard Deviation 6.8
|
11.7 Multiples of Normal Spleen Volume
Standard Deviation 7.2
|
9.3 Multiples of Normal Spleen Volume
Standard Deviation 9.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Months 12, 24 and 36Population: Intent to treat. In the Switchover group, two patients did not have MRI.
Liver volume measured by MRI. Normal liver volume is 25 mL/kg × body weight (kg).
Outcome measures
| Measure |
Switchover
n=16 Participants
Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
|
Naive 30 Units/kg
n=12 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
|
Naive 60 Units/kg
n=14 Participants
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
|
|---|---|---|---|
|
Liver Volume Multiples of Normal (MN)
Baseline
|
1.0 Multiples of Normal Liver Volume
Standard Deviation 0.1
|
1.7 Multiples of Normal Liver Volume
Standard Deviation 0.4
|
1.5 Multiples of Normal Liver Volume
Standard Deviation 0.4
|
|
Liver Volume Multiples of Normal (MN)
Month 12
|
1.1 Multiples of Normal Liver Volume
Standard Deviation 0.2
|
1.4 Multiples of Normal Liver Volume
Standard Deviation 0.3
|
1.2 Multiples of Normal Liver Volume
Standard Deviation 0.2
|
|
Liver Volume Multiples of Normal (MN)
Month 24
|
0.9 Multiples of Normal Liver Volume
Standard Deviation 0.2
|
1.3 Multiples of Normal Liver Volume
Standard Deviation 0.2
|
1.1 Multiples of Normal Liver Volume
Standard Deviation 0.2
|
|
Liver Volume Multiples of Normal (MN)
Month 36
|
1.0 Multiples of Normal Liver Volume
Standard Deviation 0.3
|
1.3 Multiples of Normal Liver Volume
Standard Deviation 0.2
|
1.1 Multiples of Normal Liver Volume
Standard Deviation 0.2
|
Adverse Events
Naive 30 Units/kg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Naive 60 Units/kg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Switchover
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Naive 30 Units/kg
n=12 participants at risk
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
|
Naive 60 Units/kg
n=14 participants at risk
Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
|
Switchover
n=18 participants at risk
Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/12 • 36 months
|
0.00%
0/14 • 36 months
|
5.6%
1/18 • Number of events 1 • 36 months
|
|
Blood and lymphatic system disorders
AUTOIMMUNE THROMBOCYTOPENIA
|
0.00%
0/12 • 36 months
|
7.1%
1/14 • Number of events 1 • 36 months
|
0.00%
0/18 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA
|
8.3%
1/12 • Number of events 1 • 36 months
|
0.00%
0/14 • 36 months
|
0.00%
0/18 • 36 months
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/12 • 36 months
|
7.1%
1/14 • Number of events 1 • 36 months
|
0.00%
0/18 • 36 months
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/12 • 36 months
|
7.1%
1/14 • Number of events 1 • 36 months
|
0.00%
0/18 • 36 months
|
|
Injury, poisoning and procedural complications
PNEUMOTHORAX TRAUMATIC
|
0.00%
0/12 • 36 months
|
0.00%
0/14 • 36 months
|
5.6%
1/18 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
8.3%
1/12 • Number of events 1 • 36 months
|
0.00%
0/14 • 36 months
|
0.00%
0/18 • 36 months
|
|
Surgical and medical procedures
RENAL STONE REMOVAL
|
0.00%
0/12 • 36 months
|
0.00%
0/14 • 36 months
|
5.6%
1/18 • Number of events 1 • 36 months
|
|
Surgical and medical procedures
TONSILLECTOMY
|
8.3%
1/12 • Number of events 1 • 36 months
|
0.00%
0/14 • 36 months
|
0.00%
0/18 • 36 months
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
8.3%
1/12 • Number of events 1 • 36 months
|
0.00%
0/14 • 36 months
|
0.00%
0/18 • 36 months
|
|
Surgical and medical procedures
VOCAL CORD POLYPECTOMY
|
8.3%
1/12 • Number of events 1 • 36 months
|
0.00%
0/14 • 36 months
|
0.00%
0/18 • 36 months
|
Other adverse events
| Measure |
Naive 30 Units/kg
n=12 participants at risk
Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
|
Naive 60 Units/kg
n=14 participants at risk
Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
|
Switchover
n=18 participants at risk
Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
33.3%
4/12 • Number of events 4 • 36 months
|
28.6%
4/14 • Number of events 4 • 36 months
|
22.2%
4/18 • Number of events 4 • 36 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
2/12 • Number of events 2 • 36 months
|
14.3%
2/14 • Number of events 2 • 36 months
|
11.1%
2/18 • Number of events 2 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/12 • 36 months
|
7.1%
1/14 • Number of events 1 • 36 months
|
16.7%
3/18 • Number of events 3 • 36 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
25.0%
3/12 • Number of events 3 • 36 months
|
0.00%
0/14 • 36 months
|
16.7%
3/18 • Number of events 3 • 36 months
|
|
Surgical and medical procedures
ENDODONTIC PROCEDURE
|
0.00%
0/12 • 36 months
|
14.3%
2/14 • Number of events 2 • 36 months
|
0.00%
0/18 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
16.7%
2/12 • Number of events 2 • 36 months
|
7.1%
1/14 • Number of events 1 • 36 months
|
0.00%
0/18 • 36 months
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
25.0%
3/12 • Number of events 3 • 36 months
|
0.00%
0/14 • 36 months
|
0.00%
0/18 • 36 months
|
|
General disorders
FATIGUE
|
16.7%
2/12 • Number of events 2 • 36 months
|
14.3%
2/14 • Number of events 2 • 36 months
|
11.1%
2/18 • Number of events 2 • 36 months
|
|
Infections and infestations
GASTROENTERITIS
|
16.7%
2/12 • Number of events 2 • 36 months
|
7.1%
1/14 • Number of events 1 • 36 months
|
5.6%
1/18 • Number of events 1 • 36 months
|
|
Nervous system disorders
HEADACHE
|
33.3%
4/12 • Number of events 4 • 36 months
|
21.4%
3/14 • Number of events 3 • 36 months
|
11.1%
2/18 • Number of events 2 • 36 months
|
|
Vascular disorders
HYPERTENSION
|
16.7%
2/12 • Number of events 2 • 36 months
|
21.4%
3/14 • Number of events 3 • 36 months
|
5.6%
1/18 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
8.3%
1/12 • Number of events 1 • 36 months
|
14.3%
2/14 • Number of events 2 • 36 months
|
0.00%
0/18 • 36 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/12 • 36 months
|
14.3%
2/14 • Number of events 2 • 36 months
|
16.7%
3/18 • Number of events 3 • 36 months
|
|
Infections and infestations
NASOPHARYNGITIS
|
16.7%
2/12 • Number of events 2 • 36 months
|
21.4%
3/14 • Number of events 3 • 36 months
|
38.9%
7/18 • Number of events 7 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
8.3%
1/12 • Number of events 1 • 36 months
|
14.3%
2/14 • Number of events 2 • 36 months
|
5.6%
1/18 • Number of events 1 • 36 months
|
|
General disorders
PAIN
|
16.7%
2/12 • Number of events 2 • 36 months
|
7.1%
1/14 • Number of events 1 • 36 months
|
5.6%
1/18 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
16.7%
2/12 • Number of events 2 • 36 months
|
28.6%
4/14 • Number of events 4 • 36 months
|
11.1%
2/18 • Number of events 2 • 36 months
|
|
Infections and infestations
PHARYNGITIS
|
16.7%
2/12 • Number of events 2 • 36 months
|
0.00%
0/14 • 36 months
|
5.6%
1/18 • Number of events 1 • 36 months
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
8.3%
1/12 • Number of events 1 • 36 months
|
14.3%
2/14 • Number of events 2 • 36 months
|
5.6%
1/18 • Number of events 1 • 36 months
|
|
General disorders
PYREXIA
|
0.00%
0/12 • 36 months
|
21.4%
3/14 • Number of events 3 • 36 months
|
22.2%
4/18 • Number of events 4 • 36 months
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/12 • 36 months
|
0.00%
0/14 • 36 months
|
11.1%
2/18 • Number of events 2 • 36 months
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/12 • 36 months
|
21.4%
3/14 • Number of events 3 • 36 months
|
11.1%
2/18 • Number of events 2 • 36 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
25.0%
3/12 • Number of events 3 • 36 months
|
21.4%
3/14 • Number of events 3 • 36 months
|
16.7%
3/18 • Number of events 3 • 36 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/12 • 36 months
|
0.00%
0/14 • 36 months
|
11.1%
2/18 • Number of events 2 • 36 months
|
|
Gastrointestinal disorders
VOMITING
|
8.3%
1/12 • Number of events 1 • 36 months
|
7.1%
1/14 • Number of events 1 • 36 months
|
16.7%
3/18 • Number of events 3 • 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place