Trial Outcomes & Findings for A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura. (NCT NCT00475423)
NCT ID: NCT00475423
Last Updated: 2015-02-23
Results Overview
Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (\>) 150x10\^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of \>50x10\^9/L over at least 2 consecutive measurements at least \<2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.
COMPLETED
PHASE2
122 participants
Week 8
2015-02-23
Participant Flow
Participant milestones
| Measure |
Rituximab
Participants received rituximab 1000 milligrams (mg) intravenously (IV) on Days 1 and 15.
|
|---|---|
|
Overall Study
STARTED
|
122
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Rituximab
Participants received rituximab 1000 milligrams (mg) intravenously (IV) on Days 1 and 15.
|
|---|---|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Lack of Efficacy
|
8
|
|
Overall Study
Death
|
1
|
|
Overall Study
Reason not specified
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
Baseline Characteristics
A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
Baseline characteristics by cohort
| Measure |
Rituximab
n=122 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 18.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Intent-to-Treat Replaced (ITTR) Population: participants who received at least 1 dose of study medication, excluded those lost to follow-up before completing treatment (reasons other than disease progression/toxicity) and/or those without documented platelet count of less than or equal to (≤)50x10\^9/L within 7 days prior to 1st rituximab infusion.
Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (\>) 150x10\^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of \>50x10\^9/L over at least 2 consecutive measurements at least \<2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)
|
43.5 percentage of participants
Interval 34.0 to 53.4
|
SECONDARY outcome
Timeframe: Week 8Population: ITTR Population
Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10\^9/L, PR ≥ 50x10\^9/L, MR equals (=) 30x10\^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Percentage of Participants With Hematological CR, PR, or Minor Response (MR)
CR
|
9.3 percentage of participants
Interval 4.5 to 16.4
|
|
Percentage of Participants With Hematological CR, PR, or Minor Response (MR)
PR
|
34.3 percentage of participants
Interval 25.4 to 44.0
|
|
Percentage of Participants With Hematological CR, PR, or Minor Response (MR)
MR
|
17.6 percentage of participants
Interval 10.9 to 26.1
|
SECONDARY outcome
Timeframe: Week 52Population: ITTR Population
CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Percentage of Participants Who Achieved CR
|
27.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: ITTR Population
Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Time to CR
|
NA days
Interval 305.0 to
Median time to CR and upper limit of the 95% confidence interval could not determined due to an insufficient number of events.
|
SECONDARY outcome
Timeframe: Week 52Population: ITTR Population
PR was defined as platelet counts \>50x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Percentage of Participants Who Achieved PR
|
56.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: ITTR Population
Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts \> 50x10\^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Time to PR
|
53.0 days
Interval 36.0 to 152.0
|
SECONDARY outcome
Timeframe: Week 52Population: ITTR Population
MR was defined as participants registered with chronic ITP with a platelet count of \>30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Percentage of Participants Who Achieved MR
|
71.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: ITTR Population
Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of \>30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Time to MR
|
22.0 days
Interval 8.0 to 30.0
|
SECONDARY outcome
Timeframe: Week 8 to Week 52Population: ITTR Population; only participants with a CR at Week 8 were included in the analysis.
The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Outcome measures
| Measure |
Rituximab 1000 mg
n=10 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Percentage of Participants With Continued CR From Week 8 to Week 52
|
10 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8 to Week 52Population: ITTR Population; only participants with a CR at Week 8 were included in the analysis.
Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Outcome measures
| Measure |
Rituximab 1000 mg
n=10 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Duration of CR in Participants With Continued CR From Week 8 Until Week 52
|
NA days
Median and 95% confidence interval (CI) could not be calculated due an insufficient number of events.
|
SECONDARY outcome
Timeframe: Week 8 to Week 52Population: ITTR Population
Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts \>50x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Outcome measures
| Measure |
Rituximab 1000 mg
n=47 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Duration of PR in Participants With Continued PR From Week 8 Until Week 52
|
247.0 days
Interval 219.0 to
Upper limit of the 95% CI could not be calculated due to inadequate data.
|
SECONDARY outcome
Timeframe: Week 8 to Week 52Population: ITTR Population
Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of \> 30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of \>30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Outcome measures
| Measure |
Rituximab 1000 mg
n=66 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Duration of MR in Participants With Continued MR From Week 8 Until Week 52
|
256.0 days
Interval 168.0 to
Upper limit of 95% CI could not be calculated due to inadequate data.
|
SECONDARY outcome
Timeframe: Week 52Population: ITTR Population
Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: ITTR Population
Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Time to Initiation of New ITP Therapy
|
314.0 days
Interval 215.0 to
Upper limit of the 95% CI could not be calculated due to censored or missing data.
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: ITTR Population
Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Percentage of Therapeutic Responders
Week 26
|
43.5 percentage of participants
|
|
Percentage of Therapeutic Responders
Week 52
|
35.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: ITTR Population
Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.
Outcome measures
| Measure |
Rituximab 1000 mg
n=108 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Percentage of Participants With a Therapeutic Response
Week 26: CR
|
38.0 percentage participants
Interval 28.8 to 47.8
|
|
Percentage of Participants With a Therapeutic Response
Week 26: PR
|
5.6 percentage participants
Interval 2.1 to 11.7
|
|
Percentage of Participants With a Therapeutic Response
Week 26: MR
|
0.0 percentage participants
Interval 0.0 to 3.4
|
|
Percentage of Participants With a Therapeutic Response
Week 26: NR
|
56.5 percentage participants
Interval 46.6 to 66.0
|
|
Percentage of Participants With a Therapeutic Response
Week 52: CR
|
35.2 percentage participants
Interval 26.2 to 45.0
|
|
Percentage of Participants With a Therapeutic Response
Week 52: PR
|
0.0 percentage participants
Interval 0.0 to 3.4
|
|
Percentage of Participants With a Therapeutic Response
Week 52: MR
|
0.0 percentage participants
Interval 0.0 to 3.4
|
|
Percentage of Participants With a Therapeutic Response
Week 52: NR
|
64.8 percentage participants
Interval 55.0 to 73.8
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last DayPopulation: Safety Analysis Population; n (number) = number of participants assessed for the specified parameter at a given visit.
Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10\^9/L.
Outcome measures
| Measure |
Rituximab 1000 mg
n=122 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Cluster of Differentiation 19 (CD19) B Cell Count
Baseline (n=84)
|
0.27 10^9 cells/L
Standard Deviation 0.374
|
|
Cluster of Differentiation 19 (CD19) B Cell Count
Week 1 (n=3)
|
0.30 10^9 cells/L
Standard Deviation 0.251
|
|
Cluster of Differentiation 19 (CD19) B Cell Count
Week 3 (n=96)
|
0.01 10^9 cells/L
Standard Deviation 0.052
|
|
Cluster of Differentiation 19 (CD19) B Cell Count
Week 8 (n=89)
|
0.01 10^9 cells/L
Standard Deviation 0.033
|
|
Cluster of Differentiation 19 (CD19) B Cell Count
Follow-up Month 4 (n=57)
|
0.01 10^9 cells/L
Standard Deviation 0.029
|
|
Cluster of Differentiation 19 (CD19) B Cell Count
Follow-up Month 6 (n=79)
|
0.03 10^9 cells/L
Standard Deviation 0.041
|
|
Cluster of Differentiation 19 (CD19) B Cell Count
Follow-up Month 8 (n=57)
|
0.07 10^9 cells/L
Standard Deviation 0.085
|
|
Cluster of Differentiation 19 (CD19) B Cell Count
Follow-up Month 10 (n=48)
|
0.15 10^9 cells/L
Standard Deviation 0.315
|
|
Cluster of Differentiation 19 (CD19) B Cell Count
Follow-up Month 12 (n=70)
|
0.18 10^9 cells/L
Standard Deviation 0.289
|
|
Cluster of Differentiation 19 (CD19) B Cell Count
Last Day (n=101)
|
0.13 10^9 cells/L
Standard Deviation 0.252
|
SECONDARY outcome
Timeframe: Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last dayPopulation: Safety Analysis Population; n=number of participants assessed for the specified parameter at a given visit.
Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10\^9/L.
Outcome measures
| Measure |
Rituximab 1000 mg
n=122 Participants
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Change From Baseline in CD19 B Cell Count
Week 3 (n=81)
|
-0.23 10^9 cells/L
Standard Deviation 0.290
|
|
Change From Baseline in CD19 B Cell Count
Week 8 (n=75)
|
-0.27 10^9 cells/L
Standard Deviation 0.393
|
|
Change From Baseline in CD19 B Cell Count
Follow-up Month 4 (n=47)
|
-0.21 10^9 cells/L
Standard Deviation 0.217
|
|
Change From Baseline in CD19 B Cell Count
Follow-up Month 6 (n=63)
|
-0.23 10^9 cells/L
Standard Deviation 0.367
|
|
Change From Baseline in CD19 B Cell Count
Follow-up Month 8 (n=44)
|
-0.22 10^9 cells/L
Standard Deviation 0.412
|
|
Change From Baseline in CD19 B Cell Count
Follow-up Month 10 (n=39)
|
-0.08 10^9 cells/L
Standard Deviation 0.207
|
|
Change From Baseline in CD19 B Cell Count
Follow-up Month 12 (n=55)
|
-0.06 10^9 cells/L
Standard Deviation 0.409
|
|
Change From Baseline in CD19 B Cell Count
Last Day (n=84)
|
-0.13 10^9 cells/L
Standard Deviation 0.389
|
Adverse Events
Rituximab 1000 mg
Serious adverse events
| Measure |
Rituximab 1000 mg
n=122 participants at risk
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.82%
1/122 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.82%
1/122 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.82%
1/122 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.82%
1/122 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.82%
1/122 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.82%
1/122 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.82%
1/122 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.82%
1/122 • Up to Week 52
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.82%
1/122 • Up to Week 52
|
|
Infections and infestations
Streptococcal Bacteraemia
|
0.82%
1/122 • Up to Week 52
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.82%
1/122 • Up to Week 52
|
|
Gastrointestinal disorders
Diarrhoea
|
0.82%
1/122 • Up to Week 52
|
|
Investigations
Platelet Count Decreased
|
0.82%
1/122 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.82%
1/122 • Up to Week 52
|
|
Vascular disorders
Haemorrhage
|
0.82%
1/122 • Up to Week 52
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.82%
1/122 • Up to Week 52
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.82%
1/122 • Up to Week 52
|
|
Psychiatric disorders
Stress
|
0.82%
1/122 • Up to Week 52
|
Other adverse events
| Measure |
Rituximab 1000 mg
n=122 participants at risk
Participants received rituximab 1000 mg IV on Days 1 and 15.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.1%
5/122 • Up to Week 52
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
4/122 • Up to Week 52
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
2/122 • Up to Week 52
|
|
Infections and infestations
Bronchitis
|
0.82%
1/122 • Up to Week 52
|
|
Infections and infestations
Ear infection
|
0.82%
1/122 • Up to Week 52
|
|
Infections and infestations
Gastroenteritis
|
0.82%
1/122 • Up to Week 52
|
|
Infections and infestations
Gastroenteritis viral
|
0.82%
1/122 • Up to Week 52
|
|
Infections and infestations
Pharyngitis
|
0.82%
1/122 • Up to Week 52
|
|
Infections and infestations
Pneumonia
|
0.82%
1/122 • Up to Week 52
|
|
Infections and infestations
Urinary tract infection
|
0.82%
1/122 • Up to Week 52
|
|
Infections and infestations
Viral infection
|
0.82%
1/122 • Up to Week 52
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
5/122 • Up to Week 52
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.5%
3/122 • Up to Week 52
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
3/122 • Up to Week 52
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
2/122 • Up to Week 52
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
2/122 • Up to Week 52
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.6%
2/122 • Up to Week 52
|
|
Gastrointestinal disorders
Abdominal distension
|
0.82%
1/122 • Up to Week 52
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.82%
1/122 • Up to Week 52
|
|
Gastrointestinal disorders
Gingival pain
|
0.82%
1/122 • Up to Week 52
|
|
Gastrointestinal disorders
Haematochezia
|
0.82%
1/122 • Up to Week 52
|
|
Gastrointestinal disorders
Melaena
|
0.82%
1/122 • Up to Week 52
|
|
Gastrointestinal disorders
Nausea
|
0.82%
1/122 • Up to Week 52
|
|
General disorders
Fatigue
|
5.7%
7/122 • Up to Week 52
|
|
General disorders
Influenza like illness
|
2.5%
3/122 • Up to Week 52
|
|
General disorders
Pyrexia
|
1.6%
2/122 • Up to Week 52
|
|
General disorders
Chest pain
|
0.82%
1/122 • Up to Week 52
|
|
General disorders
Chills
|
0.82%
1/122 • Up to Week 52
|
|
General disorders
Ill-defined disorder
|
0.82%
1/122 • Up to Week 52
|
|
General disorders
Oedema peripheral
|
0.82%
1/122 • Up to Week 52
|
|
General disorders
Pain
|
0.82%
1/122 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Contusion
|
7.4%
9/122 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Fall
|
0.82%
1/122 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.82%
1/122 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.82%
1/122 • Up to Week 52
|
|
Nervous system disorders
Headache
|
5.7%
7/122 • Up to Week 52
|
|
Nervous system disorders
Dizziness
|
1.6%
2/122 • Up to Week 52
|
|
Nervous system disorders
Lethargy
|
1.6%
2/122 • Up to Week 52
|
|
Nervous system disorders
Cognitive disorder
|
0.82%
1/122 • Up to Week 52
|
|
Nervous system disorders
Dysgeusia
|
0.82%
1/122 • Up to Week 52
|
|
Nervous system disorders
Paraesthesia
|
0.82%
1/122 • Up to Week 52
|
|
Nervous system disorders
Presyncope
|
0.82%
1/122 • Up to Week 52
|
|
Nervous system disorders
Restless legs syndrome
|
0.82%
1/122 • Up to Week 52
|
|
Nervous system disorders
Somnolence
|
0.82%
1/122 • Up to Week 52
|
|
Nervous system disorders
Tremor
|
0.82%
1/122 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.1%
5/122 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
5/122 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.6%
2/122 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.82%
1/122 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Skin pruritic
|
0.82%
1/122 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.82%
1/122 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
3/122 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
3/122 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.82%
1/122 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.82%
1/122 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.82%
1/122 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
4/122 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
3/122 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.82%
1/122 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.82%
1/122 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.82%
1/122 • Up to Week 52
|
|
Vascular disorders
Haemorrhage
|
0.82%
1/122 • Up to Week 52
|
|
Vascular disorders
Hypertension
|
1.6%
2/122 • Up to Week 52
|
|
Vascular disorders
Hot flush
|
0.82%
1/122 • Up to Week 52
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
2/122 • Up to Week 52
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.82%
1/122 • Up to Week 52
|
|
Ear and labyrinth disorders
Ear pain
|
0.82%
1/122 • Up to Week 52
|
|
Investigations
Platelet count decreased
|
1.6%
2/122 • Up to Week 52
|
|
Investigations
Intraocular pressure increased
|
0.82%
1/122 • Up to Week 52
|
|
Immune system disorders
Hypersensitivity
|
0.82%
1/122 • Up to Week 52
|
|
Immune system disorders
Seasonal allergy
|
0.82%
1/122 • Up to Week 52
|
|
Immune system disorders
Serum sickness
|
0.82%
1/122 • Up to Week 52
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.6%
2/122 • Up to Week 52
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.82%
1/122 • Up to Week 52
|
|
Eye disorders
Eye pain
|
0.82%
1/122 • Up to Week 52
|
|
Eye disorders
Eye swelling
|
0.82%
1/122 • Up to Week 52
|
|
Eye disorders
Photophobia
|
0.82%
1/122 • Up to Week 52
|
|
Eye disorders
Vision blurred
|
0.82%
1/122 • Up to Week 52
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.82%
1/122 • Up to Week 52
|
|
Cardiac disorders
Angina pectoris
|
0.82%
1/122 • Up to Week 52
|
|
Cardiac disorders
Palpitation
|
0.82%
1/122 • Up to Week 52
|
|
Metabolism and nutrition disorders
Dehydration
|
0.82%
1/122 • Up to Week 52
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.82%
1/122 • Up to Week 52
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.82%
1/122 • Up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.82%
1/122 • Up to Week 52
|
|
Psychiatric disorders
Depression
|
0.82%
1/122 • Up to Week 52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER