Trial Outcomes & Findings for Efficacy and Safety of Ferriprox® in Patients With Sickle Cell Disease or Other Anemias (NCT NCT02041299)
NCT ID: NCT02041299
Last Updated: 2021-08-10
Results Overview
LIC was measured by MRI. A score \>7 mg/g dw is indicative of iron overload.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
230 participants
Primary outcome timeframe
Change from baseline to Week 52
Results posted on
2021-08-10
Participant Flow
Participant milestones
| Measure |
Deferiprone
Patients randomized to the deferiprone arm (daily dosage of either 75 or 99 mg/kg divided into 3 equal doses, taken orally)
|
Deferoxamine
Patients randomized to the deferoxamine arm (either 20 mg/kg or up to 40 mg/kg for children, either 40 or 50 mg/kg for adults, administered as a subcutaneous infusion over 8-12 hours, 5 to 7 days a week)
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
78
|
|
Overall Study
COMPLETED
|
106
|
58
|
|
Overall Study
NOT COMPLETED
|
46
|
20
|
Reasons for withdrawal
| Measure |
Deferiprone
Patients randomized to the deferiprone arm (daily dosage of either 75 or 99 mg/kg divided into 3 equal doses, taken orally)
|
Deferoxamine
Patients randomized to the deferoxamine arm (either 20 mg/kg or up to 40 mg/kg for children, either 40 or 50 mg/kg for adults, administered as a subcutaneous infusion over 8-12 hours, 5 to 7 days a week)
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
7
|
|
Overall Study
Protocol Violation
|
11
|
4
|
|
Overall Study
Termination of the study
|
7
|
3
|
|
Overall Study
Required bone marrow transplant
|
0
|
1
|
|
Overall Study
Patient stopped dosing on unknown date
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Ferriprox® in Patients With Sickle Cell Disease or Other Anemias
Baseline characteristics by cohort
| Measure |
Deferiprone
n=152 Participants
Number of patients who received deferiprone
|
Deferoxamine
n=76 Participants
Number of patients who received deferoxamine
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
142 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
16.9 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
16.9 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Saudi Arabia
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
105 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Tunisia
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Liver iron concentration at baseline
|
16.54 mg iron per gram of liver dry weight
STANDARD_DEVIATION 7.49 • n=5 Participants
|
15.97 mg iron per gram of liver dry weight
STANDARD_DEVIATION 7.20 • n=7 Participants
|
16.26 mg iron per gram of liver dry weight
STANDARD_DEVIATION 7.30 • n=5 Participants
|
|
Cardiac iron at baseline
|
33.52 milliseconds
STANDARD_DEVIATION 6.26 • n=5 Participants
|
33.87 milliseconds
STANDARD_DEVIATION 6.17 • n=7 Participants
|
33.64 milliseconds
STANDARD_DEVIATION 6.22 • n=5 Participants
|
|
Serum ferritin level at baseline
|
4125.4 micrograms per liter
STANDARD_DEVIATION 2407.4 • n=5 Participants
|
4055.3 micrograms per liter
STANDARD_DEVIATION 2708.5 • n=7 Participants
|
4101.89 micrograms per liter
STANDARD_DEVIATION 2505.66 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to Week 52Population: Intent-to-treat population
LIC was measured by MRI. A score \>7 mg/g dw is indicative of iron overload.
Outcome measures
| Measure |
Deferiprone
n=122 Participants
Patients who received deferiprone and were evaluable for LIC and cardiac MRI T2\*
|
Deferoxamine
n=63 Participants
Patients who received deferoxamine and were evaluable for LIC and cardiac MRI T2\*
|
|---|---|---|
|
Change From Baseline in Liver Iron Concentration (LIC)
|
-4.13 mg of iron per gram of liver dry weight
Standard Error 0.50
|
-4.38 mg of iron per gram of liver dry weight
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Change from baseline to Week 52Population: Intent-to-treat population
Cardiac iron is measured by MRI in milliseconds (ms). A score of less than 20 ms is indicative of cardiac iron overload.
Outcome measures
| Measure |
Deferiprone
n=122 Participants
Patients who received deferiprone and were evaluable for LIC and cardiac MRI T2\*
|
Deferoxamine
n=63 Participants
Patients who received deferoxamine and were evaluable for LIC and cardiac MRI T2\*
|
|---|---|---|
|
Change From Baseline in Cardiac Iron
|
-0.022068 milliseconds
Standard Error 0.021133
|
-0.021773 milliseconds
Standard Error 0.025261
|
SECONDARY outcome
Timeframe: Change from baseline to Week 52Population: Intent-to-treat
Serum ferritin provides a measure of iron level in the blood. Normal levels of serum ferritin are under 300 µg/L for females and 400 µg/L for males.
Outcome measures
| Measure |
Deferiprone
n=133 Participants
Patients who received deferiprone and were evaluable for LIC and cardiac MRI T2\*
|
Deferoxamine
n=67 Participants
Patients who received deferoxamine and were evaluable for LIC and cardiac MRI T2\*
|
|---|---|---|
|
Change From Baseline in Serum Ferritin
|
-385.83 micrograms per liter
Standard Error 234.05
|
-760.89 micrograms per liter
Standard Error 289.40
|
SECONDARY outcome
Timeframe: Change from baseline to Week 52Population: Due to administrative and other issues, a majority of participants were missing scores. Evaluable data were obtained from 35 DFP and 19 DFO patients for the SF-36, and from 60 DFP and 23 DFO patients for the CHQ.
Adult patients completed the SF-36 questionnaire and minors completed the CHQ-PF50. These questionnaires yield a profile of functional health and well-being, based on 8 scales of physical and mental health measures: Physical Functioning, Role Limitations due to Physical Health, Bodily Pain, General Health Perceptions, Vitality, Social Functioning, Role Limitations due to Emotional Problems, and Mental Health (MH), and summary scores are produced for physical well-being and mental well-being. The summaries are scored from 0-100, with higher scores reflecting better outcomes.
Outcome measures
| Measure |
Deferiprone
n=95 Participants
Patients who received deferiprone and were evaluable for LIC and cardiac MRI T2\*
|
Deferoxamine
n=42 Participants
Patients who received deferoxamine and were evaluable for LIC and cardiac MRI T2\*
|
|---|---|---|
|
Change in Patient-reported Quality of Life, as Measured by the Short Form Health Survey (SF-36) or the Child Health Questionnaire (CHQ-PF50).
SF-36 Physical Summary
|
43.1 score on a scale
Standard Error 1.8
|
43.0 score on a scale
Standard Error 2.0
|
|
Change in Patient-reported Quality of Life, as Measured by the Short Form Health Survey (SF-36) or the Child Health Questionnaire (CHQ-PF50).
SF-36 Mental Summary
|
44.7 score on a scale
Standard Error 2.7
|
40.9 score on a scale
Standard Error 2.9
|
|
Change in Patient-reported Quality of Life, as Measured by the Short Form Health Survey (SF-36) or the Child Health Questionnaire (CHQ-PF50).
CHQ-PF50 Physical Summary
|
29.3 score on a scale
Standard Error 1.8
|
30.5 score on a scale
Standard Error 2.4
|
|
Change in Patient-reported Quality of Life, as Measured by the Short Form Health Survey (SF-36) or the Child Health Questionnaire (CHQ-PF50).
CHQ-PF50 Psychosocial Summary
|
42.5 score on a scale
Standard Error 1.5
|
41.3 score on a scale
Standard Error 2.1
|
Adverse Events
Deferiprone
Serious events: 40 serious events
Other events: 134 other events
Deaths: 1 deaths
Deferoxamine
Serious events: 14 serious events
Other events: 67 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Deferiprone
n=152 participants at risk
Patients randomized to the deferiprone arm will be prescribed either tablets or liquid medication.
Deferiprone
|
Deferoxamine
n=76 participants at risk
Patients randomized to the deferoxamine arm will be prescribed the drug as per the approved US prescribing information.
Deferoxamine
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Blood and lymphatic system disorders
Hypersplenism
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
4/152 • Number of events 5 • 1 year
|
1.3%
1/76 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
10.5%
16/152 • Number of events 31 • 1 year
|
5.3%
4/76 • Number of events 8 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain/upper
|
2.0%
3/152 • Number of events 3 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.66%
1/152 • Number of events 1 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.66%
1/152 • Number of events 1 • 1 year
|
2.6%
2/76 • Number of events 2 • 1 year
|
|
General disorders
Malaise
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
General disorders
Pain
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
General disorders
Pyrexia
|
3.3%
5/152 • Number of events 5 • 1 year
|
3.9%
3/76 • Number of events 5 • 1 year
|
|
Hepatobiliary disorders
Bile duct stone
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Hepatobiliary disorders
Hepatic failure
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Hepatobiliary disorders
Hepatic sequestration
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Hepatobiliary disorders
Hepatitis fulminant
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Arthritis bacterial
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Epididymitis
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Gastroenteritis viral
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Infections and infestations
Parvovirus infection
|
1.3%
2/152 • Number of events 2 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Pneumonia
|
1.3%
2/152 • Number of events 2 • 1 year
|
2.6%
2/76 • Number of events 3 • 1 year
|
|
Infections and infestations
Propionibacterium infection
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Pyelonephritis
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Sepsis
|
1.3%
2/152 • Number of events 2 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Sinusitis
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Sinusitis bacterial
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Infections and infestations
Vascular device infection
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.66%
1/152 • Number of events 1 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Investigations
Transaminases increased
|
1.3%
2/152 • Number of events 2 • 1 year
|
0.00%
0/76 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/152 • 1 year
|
2.6%
2/76 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone infarction
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
1.3%
2/152 • Number of events 2 • 1 year
|
0.00%
0/76 • 1 year
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Nervous system disorders
Migraine
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Nervous system disorders
Seizure
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.3%
2/152 • Number of events 2 • 1 year
|
0.00%
0/76 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute chest syndrome
|
2.0%
3/152 • Number of events 3 • 1 year
|
0.00%
0/76 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/152 • 1 year
|
1.3%
1/76 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Surgical and medical procedures
Hip surgery
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
|
Surgical and medical procedures
Splenectomy
|
1.3%
2/152 • Number of events 2 • 1 year
|
0.00%
0/76 • 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
1.3%
2/152 • Number of events 2 • 1 year
|
0.00%
0/76 • 1 year
|
|
Vascular disorders
Hypovolaemic shock
|
0.66%
1/152 • Number of events 1 • 1 year
|
0.00%
0/76 • 1 year
|
Other adverse events
| Measure |
Deferiprone
n=152 participants at risk
Patients randomized to the deferiprone arm will be prescribed either tablets or liquid medication.
Deferiprone
|
Deferoxamine
n=76 participants at risk
Patients randomized to the deferoxamine arm will be prescribed the drug as per the approved US prescribing information.
Deferoxamine
|
|---|---|---|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
13.8%
21/152 • Number of events 57 • 1 year
|
11.8%
9/76 • Number of events 17 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain/upper
|
24.3%
37/152 • Number of events 86 • 1 year
|
13.2%
10/76 • Number of events 13 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
6/152 • Number of events 8 • 1 year
|
6.6%
5/76 • Number of events 10 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
7.2%
11/152 • Number of events 14 • 1 year
|
7.9%
6/76 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Toothache
|
2.0%
3/152 • Number of events 3 • 1 year
|
6.6%
5/76 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
18.4%
28/152 • Number of events 59 • 1 year
|
9.2%
7/76 • Number of events 8 • 1 year
|
|
General disorders
Chest pain
|
3.3%
5/152 • Number of events 6 • 1 year
|
5.3%
4/76 • Number of events 4 • 1 year
|
|
General disorders
Injection site pain
|
0.00%
0/152 • 1 year
|
6.6%
5/76 • Number of events 6 • 1 year
|
|
General disorders
Injection site swelling
|
0.00%
0/152 • 1 year
|
5.3%
4/76 • Number of events 8 • 1 year
|
|
General disorders
Pain
|
5.3%
8/152 • Number of events 13 • 1 year
|
3.9%
3/76 • Number of events 3 • 1 year
|
|
General disorders
Pyrexia
|
26.3%
40/152 • Number of events 65 • 1 year
|
28.9%
22/76 • Number of events 33 • 1 year
|
|
Infections and infestations
Influenza
|
3.3%
5/152 • Number of events 8 • 1 year
|
6.6%
5/76 • Number of events 5 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
9.2%
14/152 • Number of events 22 • 1 year
|
11.8%
9/76 • Number of events 13 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
18/152 • Number of events 27 • 1 year
|
0.00%
0/76 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
11.2%
17/152 • Number of events 26 • 1 year
|
0.00%
0/76 • 1 year
|
|
Investigations
Neutrophil count decreased
|
7.9%
12/152 • Number of events 16 • 1 year
|
3.9%
3/76 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.9%
15/152 • Number of events 24 • 1 year
|
7.9%
6/76 • Number of events 7 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.2%
20/152 • Number of events 33 • 1 year
|
17.1%
13/76 • Number of events 25 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
38/152 • Number of events 92 • 1 year
|
34.2%
26/76 • Number of events 62 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.8%
27/152 • Number of events 36 • 1 year
|
14.5%
11/76 • Number of events 15 • 1 year
|
|
Nervous system disorders
Headache
|
19.7%
30/152 • Number of events 54 • 1 year
|
13.2%
10/76 • Number of events 17 • 1 year
|
|
Renal and urinary disorders
Chromaturia
|
5.9%
9/152 • Number of events 10 • 1 year
|
2.6%
2/76 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
12/152 • Number of events 14 • 1 year
|
14.5%
11/76 • Number of events 13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.9%
15/152 • Number of events 19 • 1 year
|
14.5%
11/76 • Number of events 13 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60