Trial Outcomes & Findings for A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease (NCT NCT01400503)
NCT ID: NCT01400503
Last Updated: 2018-05-22
Results Overview
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Up to 6 years
Results posted on
2018-05-22
Participant Flow
Participants enrolled in this study CNTO328MCD2002 included participants who were previously enrolled in study C0328T03 (NCT00412321) or CNTO328MCD2001 (NCT01024036) (either placebo or siltuximab treatment arm). A total of 60 participants from previous MCD studies C0328T03 and CNTO328MCD2001 were found eligible to be enrolled in this study.
Participant milestones
| Measure |
Siltuximab
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
Siltuximab
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
58
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease
Baseline characteristics by cohort
| Measure |
Siltuximab
n=60 Participants
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
|
|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 14.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 yearsPopulation: Safety analysis set included all enrolled participants in this study.
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Outcome measures
| Measure |
Siltuximab
n=60 Participants
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
60 Participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Population included subset of safety analysis set who previously responded to siltuximab treatment ie, did not report disease progression while receiving siltuximab in study C0328T03 or CNTO328MCD2001.
Percentage of participants maintaining disease control (defined as stable or better response) was defined as the percentage of previously responding participants who had not progressed during the long-term safety extension based on investigator assessment. A worsening in any of the measures will be considered as a progression of the disease.
Outcome measures
| Measure |
Siltuximab
n=57 Participants
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
|
|---|---|
|
Percentage of Previously Responding Participants Who Maintained Disease Control
|
96.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Population included subset of safety analysis set who were previously Siltuximab-naive i.e., received placebo in study CNTO328MCD2001 and never received siltuximab prior to enrollment in this study.
Percentage of participants experiencing disease control was defined as the percentage of siltuximab-naïve participants who had stable or better response during the long-term safety extension based on investigator's judgment. Disease control was defined as stable or better response assessed by the investigators.
Outcome measures
| Measure |
Siltuximab
n=3 Participants
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
|
|---|---|
|
Percentage of Siltuximab-naive Participants Who Experienced Disease Control
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Safety analysis set included all enrolled participants in this study.
Duration of disease control (DODC) was defined as the time from the first siltuximab administration in this study to disease progression as assessed by the investigator. Disease control was defined as stable or better response assessed by the investigators. Kaplan-Meier method was used to estimate the duration of disease control.
Outcome measures
| Measure |
Siltuximab
n=60 Participants
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
|
|---|---|
|
Duration of Disease Control
|
NA years
Median and confidence interval (CI) were not estimable due to insufficient number of participants with loss of response or disease control (due to high censorship rate).
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Safety analysis set included all enrolled participants in this study.
Overall survival was defined as the time between the first study siltuximab administration and death due to any cause. Kaplan-Meier method was used to estimate the overall survival.
Outcome measures
| Measure |
Siltuximab
n=60 Participants
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
|
|---|---|
|
Overall Survival
|
NA years
Median and CI were not estimable due to insufficient number of participants with death.
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Safety analysis set included all enrolled participants in this study.
Serum samples were screened for antibodies binding to siltuximab and number of participants positive for antibodies to siltuximab was reported.
Outcome measures
| Measure |
Siltuximab
n=60 Participants
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
|
|---|---|
|
Number of Participants Positive for Antibodies to Siltuximab
|
3 Participants
|
Adverse Events
Siltuximab
Serious events: 25 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Siltuximab
n=60 participants at risk
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Endocrine disorders
Hyperthyroidism
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Eye disorders
Vitreous Haemorrhage
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Food Poisoning
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Chest Pain
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Abscess Limb
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Anal Abscess
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Cellulitis
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Cystitis
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Device Related Infection
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Infection
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Parotitis
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Peritonitis
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Pneumonia
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Pyelonephritis
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Vulval Abscess
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Wound Infection Staphylococcal
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Avulsion Fracture
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Chest Injury
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Fractured Sacrum
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Ilium Fracture
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Testis
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Cerebrospinal Fluid Leakage
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Syncope
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Bladder Pain
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Bladder Spasm
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Dysuria
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Micturition Disorder
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Renal Colic
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Ureteral Disorder
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Urinary Retention
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Reproductive system and breast disorders
Haemorrhagic Ovarian Cyst
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein Purpura
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Surgical and medical procedures
Mastectomy
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Vascular disorders
Hypertensive Crisis
|
1.7%
1/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
Other adverse events
| Measure |
Siltuximab
n=60 participants at risk
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
|
|---|---|
|
Eye disorders
Vision Blurred
|
11.7%
7/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Abdominal Distension
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
23.3%
14/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
16.7%
10/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Anal Fistula
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Chronic Gastritis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Constipation
|
28.3%
17/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Dental Caries
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
38.3%
23/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Dry Mouth
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.3%
8/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
15.0%
9/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Gingival Pain
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Haematochezia
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Nausea
|
36.7%
22/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Oral Pain
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Tongue Ulceration
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Toothache
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
16/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Asthenia
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Catheter Site Pain
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Chest Discomfort
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Chest Pain
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Cyst
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.7%
7/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.0%
9/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.7%
7/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Cardiac disorders
Cardiac Disorder
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Cardiac disorders
Palpitations
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Ear and labyrinth disorders
Ear Pain
|
10.0%
6/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Ear and labyrinth disorders
Tympanic Membrane Perforation
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
6/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Eye disorders
Cataract
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Eye disorders
Dry Eye
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Eye disorders
Eye Irritation
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Eye disorders
Periorbital Oedema
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Fatigue
|
51.7%
31/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Generalised Oedema
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Influenza Like Illness
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Localised Oedema
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Malaise
|
13.3%
8/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Oedema
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Oedema Peripheral
|
21.7%
13/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Pain
|
11.7%
7/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Peripheral Swelling
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
General disorders
Pyrexia
|
10.0%
6/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Hepatobiliary disorders
Gallbladder Polyp
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
18.3%
11/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
11.7%
7/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Immune system disorders
Seasonal Allergy
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Acute Sinusitis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Bronchitis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Cellulitis
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Conjunctivitis
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Cystitis
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Ear Infection
|
10.0%
6/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Fungal Infection
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Furuncle
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Gastroenteritis
|
13.3%
8/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Herpes Simplex
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Herpes Zoster
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Influenza
|
10.0%
6/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Laryngitis
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Localised Infection
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Nasopharyngitis
|
18.3%
11/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Onychomycosis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Oral Candidiasis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Oral Herpes
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Otitis Media
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Pharyngitis
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Pneumonia
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Rash Pustular
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Respiratory Tract Infection
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Rhinitis
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Sinusitis
|
16.7%
10/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Skin Infection
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Tinea Infection
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Tooth Abscess
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Tooth Infection
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
66.7%
40/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Urinary Tract Infection
|
18.3%
11/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Infections and infestations
Viral Infection
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Laceration
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Investigations
Alanine Aminotransferase Increased
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Investigations
Blood Creatinine Increased
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Investigations
Blood Fibrinogen Decreased
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Investigations
Blood Phosphorus Increased
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Investigations
Haemoglobin Increased
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Investigations
Protein Total Decreased
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Investigations
Serum Ferritin Decreased
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Investigations
Weight Decreased
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Investigations
Weight Increased
|
18.3%
11/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
21.7%
13/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Enzyme Abnormality
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Gout
|
10.0%
6/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
21.7%
13/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
28.3%
17/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
16.7%
10/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
10/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
20/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
31.7%
19/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
11.7%
7/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
10.0%
6/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
18.3%
11/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
11.7%
7/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
23.3%
14/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Amnesia
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Dizziness
|
23.3%
14/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Headache
|
23.3%
14/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Memory Impairment
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Neuropathy Peripheral
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
6/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
25.0%
15/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Polyneuropathy
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Somnolence
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Nervous system disorders
Tremor
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Psychiatric disorders
Anxiety
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Psychiatric disorders
Depression
|
13.3%
8/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Psychiatric disorders
Insomnia
|
18.3%
11/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Psychiatric disorders
Nightmare
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Azotaemia
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Dysuria
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Haematuria
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Pollakiuria
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Renal Impairment
|
10.0%
6/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Renal and urinary disorders
Urinary Retention
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Reproductive system and breast disorders
Menorrhagia
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Reproductive system and breast disorders
Prostatitis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.7%
19/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.7%
13/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
25.0%
15/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
8.3%
5/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
13.3%
8/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.7%
7/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
15.0%
9/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
15.0%
9/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.7%
19/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
35.0%
21/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
26.7%
16/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Scar Pain
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
5.0%
3/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
3.3%
2/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Vascular disorders
Flushing
|
11.7%
7/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Vascular disorders
Hot Flush
|
6.7%
4/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Vascular disorders
Hypertension
|
25.0%
15/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
|
Vascular disorders
Hypotension
|
10.0%
6/60 • Up to 6 years
Safety analysis set included all enrolled participants in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER