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Trial record 1 of 1 for:    NCT02213263
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A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)

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ClinicalTrials.gov Identifier: NCT02213263
Recruitment Status : Completed
First Posted : August 11, 2014
Results First Posted : October 30, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Follicular Lymphoma
Interventions Biological: PF-05280586
Biological: MabThera®
Enrollment 394
Recruitment Details  
Pre-assignment Details A total of 394 participants were enrolled and randomized in 1:1 ratio to 1 of the 2 study treatment arms: PF-05280586 (Rituximab-Pfizer) and Rituximab-EU (MabThera®).
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg. Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Period Title: Overall Study
Started 198 196
Treated 197 196
Completed 170 170
Not Completed 28 26
Reason Not Completed
Insufficient clinical response             4             3
Lost to Follow-up             0             1
No longer willing to participate             3             4
Progressive disease             20             14
Protocol Violation             0             1
Adverse Event             1             3
Arm/Group Title Rituximab-EU PF-05280586 Total
Hide Arm/Group Description Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg. Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg. Total of all reporting groups
Overall Number of Baseline Participants 198 196 394
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 198 participants 196 participants 394 participants
58.3  (12.8) 58.7  (12.1) 58.5  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 196 participants 394 participants
Female
106
  53.5%
110
  56.1%
216
  54.8%
Male
92
  46.5%
86
  43.9%
178
  45.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 196 participants 394 participants
Hispanic or Latino
26
  13.1%
31
  15.8%
57
  14.5%
Not Hispanic or Latino
172
  86.9%
165
  84.2%
337
  85.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 196 participants 394 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
44
  22.2%
30
  15.3%
74
  18.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   0.5%
1
   0.3%
White
146
  73.7%
158
  80.6%
304
  77.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
   4.0%
7
   3.6%
15
   3.8%
1.Primary Outcome
Title Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26
Hide Description ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with the revised response criteria for malignant lymphoma (Cheson 2007). CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 198 196
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70.7
(63.8 to 76.9)
75.5
(68.9 to 81.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab-EU, PF-05280586
Comments Difference in ORR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.
Type of Statistical Test Equivalence
Comments Equivalence was tested within the pre-specified margins of (-16%, 16%) 95% confidence interval.
Method of Estimation Estimation Parameter Difference in ORR
Estimated Value 4.66
Confidence Interval (2-Sided) 95%
-4.16 to 13.47
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 197 196
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
145
  73.6%
156
  79.6%
SAEs
15
   7.6%
17
   8.7%
3.Secondary Outcome
Title Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 197 196
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
94
  47.7%
86
  43.9%
SAEs
2
   1.0%
2
   1.0%
4.Secondary Outcome
Title Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
Hide Description An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 197 196
Measure Type: Count of Participants
Unit of Measure: Participants
26
  13.2%
28
  14.3%
5.Secondary Outcome
Title Number of Participants With Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
Hide Description Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated; Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 197 196
Measure Type: Count of Participants
Unit of Measure: Participants
8
   4.1%
9
   4.6%
6.Secondary Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities
Hide Description Criteria for clinically significant laboratory abnormalities included total bilirubin (TB) less than (<) 2*upper limit of normal (ULN), alanine aminotransferase (ALT)<3*ULN; TB<2*ULN, ALT more than (>) 3 equal to (=) *ULN; TB<2*ULN, aspartate aminotransferase (AST)<3*ULN; TB<2*ULN, AST>=3*ULN. Data for only those categories are reported for which at least one participant had clinically significant laboratory abnormality.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 197 195
Measure Type: Count of Participants
Unit of Measure: Participants
TB<2*ULN, ALT<3*ULN
194
  98.5%
192
  98.5%
TB<2*ULN, ALT>=3*ULN
3
   1.5%
3
   1.5%
TB<2*ULN, AST<3*ULN
196
  99.5%
195
 100.0%
TB<2*ULN, AST>=3*ULN
1
   0.5%
0
   0.0%
7.Secondary Outcome
Title Time to Treatment Failure (TTF)
Hide Description TTF was defined as the time (in months) from date of randomization to first progression of disease based on central review, death due to any cause, or permanent discontinuation from treatment, or discontinuation from study for any reason, whichever came first. Progression was defined as any new lesion or increase by greater than or equal to (>=) 50% of previously involved sites from nadir. TTF was calculated using Kaplan-Meier method.
Time Frame From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 48 54
Median (95% Confidence Interval)
Unit of Measure: months
18.9
(12.6 to 18.9)
NA [1] 
(12.3 to NA)
[1]
Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab-EU, PF-05280586
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.450
Comments A log-rank test stratified by follicular lymphoma international prognostic index 2 (FLIPI2) risk was used to compare the treatment groups with respect to TTF at a 2-sided alpha level of 0.05.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.163
Confidence Interval (2-Sided) 95%
0.786 to 1.720
Estimation Comments Hazard ratio and its confidence intervals (CIs) were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.
8.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time (in months) from date of randomization to first progression of disease (PD) based on central review or death due to any cause in the absence of documented PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method.
Time Frame From randomization until disease progression or death due to any cause or up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 28 37
Median (95% Confidence Interval)
Unit of Measure: months
18.9
(12.6 to 18.9)
NA [1] 
(NA to NA)
[1]
Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab-EU, PF-05280586
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.189
Comments [Not Specified]
Method Log Rank
Comments A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to PFS at a 2-sided alpha level of 0.05.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.393
Confidence Interval (2-Sided) 95%
0.847 to 2.291
Estimation Comments Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.
9.Secondary Outcome
Title Percentage of Participants With Complete Remission (CR) at Week 26
Hide Description Complete Remission (CR) was defined as disappearance of all evidence of disease. CR was assessed by central review based on scans done at Week 26.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 198 196
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.3
(22.1 to 35.1)
26.0
(20.0 to 32.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab-EU, PF-05280586
Comments Difference in CR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.31
Confidence Interval (2-Sided) 95%
-11.09 to 6.50
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined as the time (in months) from date of the first documentation of overall response (CR or PR) to the first documentation of progressive disease (PD) based on central review or to death due to any cause in the absence of documented PD. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method.
Time Frame From date of first documentation of overall response to first documentation of PD or to death due to any cause in absence of PD or up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The response-evaluable population was defined as all randomized participants who received at least 1 dose of study drug, had adequate disease assessment at baseline, and at least 1 post baseline response assessment. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 19 28
Median (95% Confidence Interval)
Unit of Measure: months
15.4
(10.4 to 15.4)
NA [1] 
(9.6 to NA)
[1]
Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab-EU, PF-05280586
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.185
Comments A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to DOR at a 2-sided alpha level of 0.05.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.492
Confidence Interval (2-Sided) 95%
0.823 to 2.704
Estimation Comments Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.
11.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time (in months) from date of randomization to death due to any cause. For participants who were alive, overall survival was censored at the last contact. Overall survival was calculated using Kaplan-Meier method.
Time Frame From randomization until death due to any cause or up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 198 196
Median (95% Confidence Interval)
Unit of Measure: months
18.9 [1] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
Due to single participant with an event, lower and upper limit of 95% CI could not be calculated.
[2]
Due to single participant with an event, median, lower and upper limit of 95% CI could not be calculated.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab-EU, PF-05280586
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.319
Comments A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to overall survival at a 2-sided alpha level of 0.05.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.94
Confidence Interval (2-Sided) 95%
0.000
Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.
Estimation Comments Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.
12.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU
Hide Description [Not Specified]
Time Frame Predose (within 4 hours prior to start of infusion) on Days 1, 8, 15 and 22; within 15 minutes prior to end of infusion on Days 1 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKAS) included participants who received at least 1 dose of any study drug and who provided at least one post-dose pharmacokinetic concentration. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 132 138
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
334848.88
(33%)
337708.05
(36%)
13.Secondary Outcome
Title Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU
Hide Description [Not Specified]
Time Frame Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKAS) included participants who received at least 1 dose of any study drug and who provided at least one post-dose pharmacokinetic concentration. Here 'Number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 197 196
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 1 Number Analyzed 195 participants 192 participants
0.01
(577%)
0.01
(1320%)
Day 8 Number Analyzed 197 participants 194 participants
62311.74
(47%)
66669.15
(45%)
Day 15 Number Analyzed 194 participants 193 participants
109619.73
(43%)
119026.91
(29%)
Day 22 Number Analyzed 194 participants 194 participants
144650.79
(68%)
158294.91
(32%)
14.Secondary Outcome
Title Cluster of Differentiation (CD) 19-Positive B-Cell Counts
Hide Description [Not Specified]
Time Frame Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT (mITT) Population included all participants who were randomized and received at least 1 dose of any study drug. Here 'Number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 197 196
Median (Full Range)
Unit of Measure: Cells per microliter
Baseline Number Analyzed 173 participants 175 participants
114.2
(0.6 to 2313.1)
119.9
(10.9 to 1310.1)
Week 2 Number Analyzed 168 participants 159 participants
1.0
(0.2 to 44.8)
0.8
(0.2 to 136.0)
Week 3 Number Analyzed 149 participants 149 participants
0.6
(0.2 to 19.5)
0.6
(0.2 to 248.1)
Week 4 Number Analyzed 143 participants 114 participants
0.5
(0.2 to 8.7)
0.4
(0.2 to 144.5)
Week 5 Number Analyzed 118 participants 128 participants
0.5
(0.2 to 19.0)
0.4
(0.2 to 19.0)
Week 13 Number Analyzed 106 participants 103 participants
0.5
(0.2 to 130.7)
0.5
(0.2 to 183.7)
Week 26 Number Analyzed 142 participants 123 participants
1.2
(0.2 to 496.5)
0.9
(0.2 to 329.8)
Week 39 Number Analyzed 157 participants 135 participants
21.7
(0.3 to 341.0)
10.7
(0.2 to 442.7)
Week 52 Number Analyzed 151 participants 147 participants
60.8
(1.4 to 413.0)
51.6
(0.3 to 597.9)
15.Secondary Outcome
Title Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Hide Description Human serum ADA samples were analyzed for the presence or absence of anti-rituximab antibodies or anti-PF-05280586 antibodies using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Human NAb serum samples testing ADA positive were analyzed for the presence or absence of neutralizing anti-rituximab antibody and neutralizing anti-PF-05280586 antibody using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Participants with their ADA titer >= 1.88 were considered to be ADA positive. Only participants with a positive ADA result were further tested for NAb.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of any study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 197 195
Measure Type: Count of Participants
Unit of Measure: Participants
ADA Positive Number Analyzed 197 participants 195 participants
39
  19.8%
43
  22.1%
NAB Positive Number Analyzed 39 participants 43 participants
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Number of Participants Reporting Immune-Based Adverse Effects
Hide Description Immune-based adverse effects included infusion related reaction (IRR), adverse events which fulfill Sampson’s criteria, and adverse events which belong to the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) anaphylaxis or hypersensitivity reactions. Potential allergic and anaphylactic reactions were identified programmatically based on the criteria of Sampson et al, (2006).
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety analysis population include all participants who received at least 1 dose of any study treatment.
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description:
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
Overall Number of Participants Analyzed 197 196
Measure Type: Count of Participants
Unit of Measure: Participants
IRR reported
59
  29.9%
49
  25.0%
AE based on Sampson’s criteria
17
   8.6%
17
   8.7%
Anaphylaxis/Hypersensitivity (SMQ)
48
  24.4%
39
  19.9%
Time Frame Baseline up to end of study (up to 52 weeks)
Adverse Event Reporting Description Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.
 
Arm/Group Title Rituximab-EU PF-05280586
Hide Arm/Group Description Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg. Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
All-Cause Mortality
Rituximab-EU PF-05280586
Affected / at Risk (%) Affected / at Risk (%)
Total   1/197 (0.51%)   1/196 (0.51%) 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab-EU PF-05280586
Affected / at Risk (%) Affected / at Risk (%)
Total   15/197 (7.61%)   17/196 (8.67%) 
Cardiac disorders     
Angina unstable * 1  1/197 (0.51%)  0/196 (0.00%) 
Atrial fibrillation * 1  0/197 (0.00%)  1/196 (0.51%) 
Intracardiac thrombus * 1  1/197 (0.51%)  0/196 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/197 (0.00%)  1/196 (0.51%) 
Mesenteric artery stenosis * 1  0/197 (0.00%)  1/196 (0.51%) 
Ileus * 1  0/197 (0.00%)  1/196 (0.51%) 
Inguinal hernia * 1  1/197 (0.51%)  0/196 (0.00%) 
General disorders     
Disease progression * 1  1/197 (0.51%)  1/196 (0.51%) 
Non-cardiac chest pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Pyrexia * 1  0/197 (0.00%)  1/196 (0.51%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/197 (0.51%)  0/196 (0.00%) 
Immune system disorders     
Serum sickness * 1  1/197 (0.51%)  0/196 (0.00%) 
Infections and infestations     
Appendicitis * 1  0/197 (0.00%)  1/196 (0.51%) 
Clostridium difficile infection * 1  0/197 (0.00%)  1/196 (0.51%) 
Diverticulitis * 1  0/197 (0.00%)  1/196 (0.51%) 
Escherichia sepsis * 1  1/197 (0.51%)  0/196 (0.00%) 
Hepatitis B * 1  1/197 (0.51%)  0/196 (0.00%) 
Kidney infection * 1  1/197 (0.51%)  0/196 (0.00%) 
Peritonitis * 1  0/197 (0.00%)  1/196 (0.51%) 
Urinary tract infection * 1  0/197 (0.00%)  1/196 (0.51%) 
Viral sinusitis * 1  1/197 (0.51%)  0/196 (0.00%) 
Injury, poisoning and procedural complications     
Contusion * 1  0/197 (0.00%)  1/196 (0.51%) 
Infusion related reaction * 1  1/197 (0.51%)  0/196 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc disorder * 1  0/197 (0.00%)  1/196 (0.51%) 
Polyarthritis * 1  1/197 (0.51%)  0/196 (0.00%) 
Spinal column stenosis * 1  1/197 (0.51%)  0/196 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer * 1  1/197 (0.51%)  0/196 (0.00%) 
Lung adenocarcinoma stage I * 1  0/197 (0.00%)  1/196 (0.51%) 
Prostate cancer * 1  0/197 (0.00%)  1/196 (0.51%) 
Squamous cell carcinoma of lung * 1  1/197 (0.51%)  0/196 (0.00%) 
Uterine cancer * 1  0/197 (0.00%)  1/196 (0.51%) 
Colon adenoma * 1  0/197 (0.00%)  1/196 (0.51%) 
Nervous system disorders     
Paraesthesia * 1  0/197 (0.00%)  1/196 (0.51%) 
Transient ischaemic attack * 1  0/197 (0.00%)  1/196 (0.51%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/197 (0.51%)  0/196 (0.00%) 
Pulmonary embolism * 1  1/197 (0.51%)  0/196 (0.00%) 
1
Term from vocabulary, MedDRA (v20.1)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab-EU PF-05280586
Affected / at Risk (%) Affected / at Risk (%)
Total   143/197 (72.59%)   153/196 (78.06%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/197 (0.51%)  1/196 (0.51%) 
Lymph node pain * 1  0/197 (0.00%)  1/196 (0.51%) 
Lymphopenia * 1  1/197 (0.51%)  1/196 (0.51%) 
Neutropenia * 1  3/197 (1.52%)  1/196 (0.51%) 
Thrombocytopenia * 1  1/197 (0.51%)  0/196 (0.00%) 
Cardiac disorders     
Angina pectoris * 1  1/197 (0.51%)  0/196 (0.00%) 
Angina unstable * 1  1/197 (0.51%)  0/196 (0.00%) 
Atrial fibrillation * 1  0/197 (0.00%)  2/196 (1.02%) 
Bradycardia * 1  1/197 (0.51%)  0/196 (0.00%) 
Cardiac failure congestive * 1  0/197 (0.00%)  1/196 (0.51%) 
Palpitations * 1  2/197 (1.02%)  5/196 (2.55%) 
Sinus bradycardia * 1  1/197 (0.51%)  0/196 (0.00%) 
Tachycardia * 1  2/197 (1.02%)  0/196 (0.00%) 
Ear and labyrinth disorders     
Ear discomfort * 1  0/197 (0.00%)  2/196 (1.02%) 
Ear disorder * 1  0/197 (0.00%)  1/196 (0.51%) 
Ear pain * 1  1/197 (0.51%)  1/196 (0.51%) 
Ear pruritus * 1  2/197 (1.02%)  3/196 (1.53%) 
Hypoacusis * 1  2/197 (1.02%)  2/196 (1.02%) 
Tinnitus * 1  1/197 (0.51%)  1/196 (0.51%) 
Vertigo * 1  3/197 (1.52%)  2/196 (1.02%) 
Vertigo positional * 1  1/197 (0.51%)  0/196 (0.00%) 
Endocrine disorders     
Hyperthyroidism * 1  1/197 (0.51%)  0/196 (0.00%) 
Hypothyroidism * 1  2/197 (1.02%)  0/196 (0.00%) 
Thyroid cyst * 1  0/197 (0.00%)  1/196 (0.51%) 
Eye disorders     
Accommodation disorder * 1  0/197 (0.00%)  1/196 (0.51%) 
Cataract * 1  1/197 (0.51%)  2/196 (1.02%) 
Conjunctival disorder * 1  1/197 (0.51%)  0/196 (0.00%) 
Diplopia * 1  1/197 (0.51%)  0/196 (0.00%) 
Dry eye * 1  2/197 (1.02%)  0/196 (0.00%) 
Erythema of eyelid * 1  0/197 (0.00%)  1/196 (0.51%) 
Eye pruritus * 1  3/197 (1.52%)  0/196 (0.00%) 
Lacrimation increased * 1  1/197 (0.51%)  0/196 (0.00%) 
Meibomianitis * 1  1/197 (0.51%)  0/196 (0.00%) 
Ocular hyperaemia * 1  1/197 (0.51%)  0/196 (0.00%) 
Entropion * 1  0/197 (0.00%)  1/196 (0.51%) 
Visual impairment * 1  0/197 (0.00%)  1/196 (0.51%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  1/197 (0.51%)  1/196 (0.51%) 
Abdominal pain * 1  3/197 (1.52%)  7/196 (3.57%) 
Abdominal pain lower * 1  0/197 (0.00%)  1/196 (0.51%) 
Abdominal pain upper * 1  5/197 (2.54%)  9/196 (4.59%) 
Cheilitis * 1  0/197 (0.00%)  1/196 (0.51%) 
Chronic gastritis * 1  0/197 (0.00%)  1/196 (0.51%) 
Colitis * 1  0/197 (0.00%)  1/196 (0.51%) 
Constipation * 1  8/197 (4.06%)  8/196 (4.08%) 
Dental caries * 1  0/197 (0.00%)  2/196 (1.02%) 
Diarrhoea * 1  12/197 (6.09%)  14/196 (7.14%) 
Diverticulum intestinal * 1  1/197 (0.51%)  0/196 (0.00%) 
Dry mouth * 1  1/197 (0.51%)  0/196 (0.00%) 
Dyspepsia * 1  2/197 (1.02%)  5/196 (2.55%) 
Dysphagia * 1  1/197 (0.51%)  0/196 (0.00%) 
Enterocolitis * 1  0/197 (0.00%)  1/196 (0.51%) 
Faeces soft * 1  1/197 (0.51%)  0/196 (0.00%) 
Flatulence * 1  0/197 (0.00%)  1/196 (0.51%) 
Functional gastrointestinal disorder * 1  1/197 (0.51%)  0/196 (0.00%) 
Gastritis * 1  0/197 (0.00%)  1/196 (0.51%) 
Gastrointestinal disorder * 1  0/197 (0.00%)  3/196 (1.53%) 
Gastrooesophageal reflux disease * 1  0/197 (0.00%)  1/196 (0.51%) 
Gingival pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Gingival swelling * 1  0/197 (0.00%)  1/196 (0.51%) 
Haematochezia * 1  1/197 (0.51%)  0/196 (0.00%) 
Haemorrhoids * 1  2/197 (1.02%)  0/196 (0.00%) 
Inguinal hernia * 1  1/197 (0.51%)  0/196 (0.00%) 
Lip oedema * 1  1/197 (0.51%)  0/196 (0.00%) 
Mouth swelling * 1  0/197 (0.00%)  1/196 (0.51%) 
Nausea * 1  17/197 (8.63%)  15/196 (7.65%) 
Odynophagia * 1  1/197 (0.51%)  1/196 (0.51%) 
Oral discomfort * 1  0/197 (0.00%)  1/196 (0.51%) 
Oral mucosal erythema * 1  0/197 (0.00%)  1/196 (0.51%) 
Paraesthesia oral * 1  1/197 (0.51%)  0/196 (0.00%) 
Periodontal disease * 1  1/197 (0.51%)  0/196 (0.00%) 
Rectal haemorrhage * 1  0/197 (0.00%)  1/196 (0.51%) 
Salivary gland pain * 1  0/197 (0.00%)  1/196 (0.51%) 
Stomatitis * 1  3/197 (1.52%)  0/196 (0.00%) 
Swollen tongue * 1  0/197 (0.00%)  1/196 (0.51%) 
Tooth disorder * 1  0/197 (0.00%)  1/196 (0.51%) 
Toothache * 1  2/197 (1.02%)  2/196 (1.02%) 
Vomiting * 1  7/197 (3.55%)  3/196 (1.53%) 
General disorders     
Asthenia * 1  13/197 (6.60%)  9/196 (4.59%) 
Axillary pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Catheter site pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Catheter site related reaction * 1  1/197 (0.51%)  0/196 (0.00%) 
Chest discomfort * 1  1/197 (0.51%)  2/196 (1.02%) 
Chest pain * 1  3/197 (1.52%)  2/196 (1.02%) 
Chills * 1  3/197 (1.52%)  3/196 (1.53%) 
Discomfort * 1  1/197 (0.51%)  0/196 (0.00%) 
Face oedema * 1  0/197 (0.00%)  1/196 (0.51%) 
Facial pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Fatigue * 1  13/197 (6.60%)  12/196 (6.12%) 
Feeling abnormal * 1  1/197 (0.51%)  0/196 (0.00%) 
Feeling cold * 1  0/197 (0.00%)  1/196 (0.51%) 
Feeling hot * 1  2/197 (1.02%)  2/196 (1.02%) 
Generalised oedema * 1  0/197 (0.00%)  2/196 (1.02%) 
Influenza like illness * 1  4/197 (2.03%)  2/196 (1.02%) 
Infusion site bruising * 1  1/197 (0.51%)  0/196 (0.00%) 
General physical health deterioration * 1  1/197 (0.51%)  0/196 (0.00%) 
Infusion site erythema * 1  1/197 (0.51%)  0/196 (0.00%) 
Infusion site extravasation * 1  1/197 (0.51%)  0/196 (0.00%) 
Infusion site pain * 1  0/197 (0.00%)  1/196 (0.51%) 
Malaise * 1  0/197 (0.00%)  3/196 (1.53%) 
Non-cardiac chest pain * 1  1/197 (0.51%)  1/196 (0.51%) 
Oedema * 1  1/197 (0.51%)  2/196 (1.02%) 
Oedema peripheral * 1  7/197 (3.55%)  2/196 (1.02%) 
Pain * 1  3/197 (1.52%)  3/196 (1.53%) 
Peripheral swelling * 1  1/197 (0.51%)  0/196 (0.00%) 
Pyrexia * 1  11/197 (5.58%)  11/196 (5.61%) 
Suprapubic pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Swelling * 1  0/197 (0.00%)  1/196 (0.51%) 
Hepatobiliary disorders     
Hepatic steatosis * 1  1/197 (0.51%)  0/196 (0.00%) 
Hepatocellular injury * 1  0/197 (0.00%)  1/196 (0.51%) 
Immune system disorders     
Contrast media allergy * 1  1/197 (0.51%)  2/196 (1.02%) 
Cytokine release syndrome * 1  0/197 (0.00%)  1/196 (0.51%) 
Drug hypersensitivity * 1  0/197 (0.00%)  1/196 (0.51%) 
Hypersensitivity * 1  1/197 (0.51%)  0/196 (0.00%) 
Hypogammaglobulinaemia * 1  1/197 (0.51%)  0/196 (0.00%) 
Infections and infestations     
Acarodermatitis * 1  0/197 (0.00%)  1/196 (0.51%) 
Acute sinusitis * 1  1/197 (0.51%)  1/196 (0.51%) 
Atypical mycobacterial infection * 1  1/197 (0.51%)  0/196 (0.00%) 
Bronchitis * 1  7/197 (3.55%)  3/196 (1.53%) 
Cellulitis * 1  0/197 (0.00%)  1/196 (0.51%) 
Conjunctivitis * 1  3/197 (1.52%)  0/196 (0.00%) 
Cystitis * 1  3/197 (1.52%)  1/196 (0.51%) 
Cystitis bacterial * 1  1/197 (0.51%)  0/196 (0.00%) 
Diverticulitis * 1  0/197 (0.00%)  1/196 (0.51%) 
Enteritis infectious * 1  1/197 (0.51%)  0/196 (0.00%) 
Folliculitis * 1  1/197 (0.51%)  0/196 (0.00%) 
Gastroenteritis * 1  3/197 (1.52%)  2/196 (1.02%) 
Genital herpes * 1  0/197 (0.00%)  1/196 (0.51%) 
Gingivitis * 1  1/197 (0.51%)  0/196 (0.00%) 
Herpes zoster * 1  3/197 (1.52%)  1/196 (0.51%) 
Infected bite * 1  1/197 (0.51%)  0/196 (0.00%) 
Influenza * 1  6/197 (3.05%)  4/196 (2.04%) 
Laryngitis * 1  1/197 (0.51%)  0/196 (0.00%) 
Nasopharyngitis * 1  9/197 (4.57%)  5/196 (2.55%) 
Oral herpes * 1  2/197 (1.02%)  3/196 (1.53%) 
Otitis externa fungal * 1  1/197 (0.51%)  0/196 (0.00%) 
Paronychia * 1  0/197 (0.00%)  1/196 (0.51%) 
Pertussis * 1  1/197 (0.51%)  0/196 (0.00%) 
Pharyngitis * 1  4/197 (2.03%)  4/196 (2.04%) 
Pneumonia * 1  0/197 (0.00%)  1/196 (0.51%) 
Purulence * 1  0/197 (0.00%)  1/196 (0.51%) 
Respiratory tract infection * 1  1/197 (0.51%)  3/196 (1.53%) 
Rhinitis * 1  3/197 (1.52%)  1/196 (0.51%) 
Sinusitis * 1  2/197 (1.02%)  5/196 (2.55%) 
Skin infection * 1  2/197 (1.02%)  0/196 (0.00%) 
Sycosis barbae * 1  1/197 (0.51%)  0/196 (0.00%) 
Systemic infection * 1  1/197 (0.51%)  0/196 (0.00%) 
Tracheitis * 1  0/197 (0.00%)  1/196 (0.51%) 
Trichophytosis * 1  1/197 (0.51%)  0/196 (0.00%) 
Upper respiratory tract infection * 1  5/197 (2.54%)  9/196 (4.59%) 
Urinary tract infection * 1  5/197 (2.54%)  4/196 (2.04%) 
Viral infection * 1  0/197 (0.00%)  1/196 (0.51%) 
Viral pharyngitis * 1  2/197 (1.02%)  0/196 (0.00%) 
Viral upper respiratory tract infection * 1  1/197 (0.51%)  0/196 (0.00%) 
Injury, poisoning and procedural complications     
Bone contusion * 1  0/197 (0.00%)  1/196 (0.51%) 
Chest injury * 1  1/197 (0.51%)  1/196 (0.51%) 
Contusion * 1  1/197 (0.51%)  2/196 (1.02%) 
Fall * 1  2/197 (1.02%)  5/196 (2.55%) 
Hand fracture * 1  1/197 (0.51%)  0/196 (0.00%) 
Head injury * 1  2/197 (1.02%)  0/196 (0.00%) 
Humerus fracture * 1  1/197 (0.51%)  0/196 (0.00%) 
Infusion related reaction * 1  58/197 (29.44%)  49/196 (25.00%) 
Laceration * 1  2/197 (1.02%)  0/196 (0.00%) 
Limb injury * 1  0/197 (0.00%)  2/196 (1.02%) 
Neck injury * 1  1/197 (0.51%)  0/196 (0.00%) 
Post procedural haemorrhage * 1  0/197 (0.00%)  1/196 (0.51%) 
Road traffic accident * 1  1/197 (0.51%)  0/196 (0.00%) 
Skin abrasion * 1  0/197 (0.00%)  1/196 (0.51%) 
Suture related complication * 1  1/197 (0.51%)  0/196 (0.00%) 
Suture rupture * 1  1/197 (0.51%)  0/196 (0.00%) 
Tendon rupture * 1  1/197 (0.51%)  0/196 (0.00%) 
Thermal burn * 1  1/197 (0.51%)  1/196 (0.51%) 
Upper limb fracture * 1  0/197 (0.00%)  1/196 (0.51%) 
Wound complication * 1  2/197 (1.02%)  0/196 (0.00%) 
Wrist fracture * 1  0/197 (0.00%)  1/196 (0.51%) 
Incision site pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Procedural pain * 1  0/197 (0.00%)  1/196 (0.51%) 
Investigations     
Alanine aminotransferase increased * 1  3/197 (1.52%)  0/196 (0.00%) 
Aspartate aminotransferase increased * 1  1/197 (0.51%)  1/196 (0.51%) 
Blood bilirubin increased * 1  1/197 (0.51%)  0/196 (0.00%) 
Blood creatinine increased * 1  0/197 (0.00%)  1/196 (0.51%) 
Blood glucose increased * 1  0/197 (0.00%)  1/196 (0.51%) 
Blood lactate dehydrogenase increased * 1  1/197 (0.51%)  3/196 (1.53%) 
Blood potassium increased * 1  1/197 (0.51%)  0/196 (0.00%) 
Blood pressure decreased * 1  2/197 (1.02%)  0/196 (0.00%) 
Blood pressure increased * 1  1/197 (0.51%)  1/196 (0.51%) 
Blood thyroid stimulating hormone increased * 1  0/197 (0.00%)  1/196 (0.51%) 
Blood urine present * 1  1/197 (0.51%)  0/196 (0.00%) 
C-reactive protein increased * 1  1/197 (0.51%)  0/196 (0.00%) 
Gamma-glutamyltransferase increased * 1  1/197 (0.51%)  1/196 (0.51%) 
Lymphocyte count decreased * 1  1/197 (0.51%)  1/196 (0.51%) 
Neutrophil count decreased * 1  0/197 (0.00%)  5/196 (2.55%) 
Neutrophil count increased * 1  1/197 (0.51%)  0/196 (0.00%) 
Serum ferritin decreased * 1  0/197 (0.00%)  1/196 (0.51%) 
Weight decreased * 1  1/197 (0.51%)  0/196 (0.00%) 
White blood cell count decreased * 1  1/197 (0.51%)  4/196 (2.04%) 
Breath sounds abnormal * 1  1/197 (0.51%)  1/196 (0.51%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/197 (0.51%)  2/196 (1.02%) 
Dehydration * 1  0/197 (0.00%)  2/196 (1.02%) 
Diabetes mellitus * 1  0/197 (0.00%)  2/196 (1.02%) 
Dyslipidaemia * 1  0/197 (0.00%)  1/196 (0.51%) 
Fluid retention * 1  1/197 (0.51%)  0/196 (0.00%) 
Hypercholesterolaemia * 1  1/197 (0.51%)  1/196 (0.51%) 
Hyperglycaemia * 1  4/197 (2.03%)  1/196 (0.51%) 
Hypertriglyceridaemia * 1  1/197 (0.51%)  3/196 (1.53%) 
Hyperuricaemia * 1  2/197 (1.02%)  0/196 (0.00%) 
Hypoglycaemia * 1  1/197 (0.51%)  0/196 (0.00%) 
Hypokalaemia * 1  1/197 (0.51%)  0/196 (0.00%) 
Type 2 diabetes mellitus * 1  1/197 (0.51%)  1/196 (0.51%) 
Vitamin D deficiency * 1  1/197 (0.51%)  1/196 (0.51%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  6/197 (3.05%)  7/196 (3.57%) 
Back pain * 1  10/197 (5.08%)  8/196 (4.08%) 
Bone loss * 1  0/197 (0.00%)  1/196 (0.51%) 
Bone pain * 1  3/197 (1.52%)  0/196 (0.00%) 
Costochondritis * 1  1/197 (0.51%)  0/196 (0.00%) 
Flank pain * 1  2/197 (1.02%)  1/196 (0.51%) 
Groin pain * 1  2/197 (1.02%)  3/196 (1.53%) 
Haemarthrosis * 1  1/197 (0.51%)  0/196 (0.00%) 
Intervertebral disc protrusion * 1  1/197 (0.51%)  0/196 (0.00%) 
Joint effusion * 1  1/197 (0.51%)  0/196 (0.00%) 
Joint stiffness * 1  1/197 (0.51%)  1/196 (0.51%) 
Joint swelling * 1  1/197 (0.51%)  1/196 (0.51%) 
Muscle contracture * 1  0/197 (0.00%)  1/196 (0.51%) 
Muscle spasms * 1  1/197 (0.51%)  0/196 (0.00%) 
Muscle twitching * 1  0/197 (0.00%)  1/196 (0.51%) 
Muscular weakness * 1  2/197 (1.02%)  1/196 (0.51%) 
Musculoskeletal chest pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Musculoskeletal discomfort * 1  0/197 (0.00%)  2/196 (1.02%) 
Musculoskeletal pain * 1  2/197 (1.02%)  1/196 (0.51%) 
Musculoskeletal stiffness * 1  2/197 (1.02%)  2/196 (1.02%) 
Myalgia * 1  5/197 (2.54%)  9/196 (4.59%) 
Neck pain * 1  3/197 (1.52%)  2/196 (1.02%) 
Osteoarthritis * 1  1/197 (0.51%)  0/196 (0.00%) 
Pain in extremity * 1  4/197 (2.03%)  7/196 (3.57%) 
Posture abnormal * 1  1/197 (0.51%)  0/196 (0.00%) 
Pubic pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Spinal osteoarthritis * 1  1/197 (0.51%)  0/196 (0.00%) 
Spinal pain * 1  2/197 (1.02%)  2/196 (1.02%) 
Spondylolisthesis * 1  1/197 (0.51%)  0/196 (0.00%) 
Tendon calcification * 1  0/197 (0.00%)  1/196 (0.51%) 
Tendonitis * 1  1/197 (0.51%)  1/196 (0.51%) 
Periarthritis * 1  1/197 (0.51%)  0/196 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  2/197 (1.02%)  1/196 (0.51%) 
Infected neoplasm * 1  1/197 (0.51%)  0/196 (0.00%) 
Lung adenocarcinoma stage I * 1  0/197 (0.00%)  1/196 (0.51%) 
Meningioma * 1  0/197 (0.00%)  1/196 (0.51%) 
Non-Hodgkin’s lymphoma * 1  0/197 (0.00%)  1/196 (0.51%) 
Nervous system disorders     
Burning sensation * 1  1/197 (0.51%)  1/196 (0.51%) 
Dizziness * 1  6/197 (3.05%)  2/196 (1.02%) 
Dysgeusia * 1  1/197 (0.51%)  0/196 (0.00%) 
Head discomfort * 1  0/197 (0.00%)  1/196 (0.51%) 
Headache * 1  19/197 (9.64%)  16/196 (8.16%) 
Hypoaesthesia * 1  1/197 (0.51%)  1/196 (0.51%) 
Hypotonia * 1  0/197 (0.00%)  1/196 (0.51%) 
Intercostal neuralgia * 1  0/197 (0.00%)  1/196 (0.51%) 
Lethargy * 1  0/197 (0.00%)  1/196 (0.51%) 
Migraine * 1  0/197 (0.00%)  1/196 (0.51%) 
Nerve compression * 1  0/197 (0.00%)  1/196 (0.51%) 
Neuralgia * 1  1/197 (0.51%)  0/196 (0.00%) 
Neuropathy peripheral * 1  1/197 (0.51%)  1/196 (0.51%) 
Paraesthesia * 1  3/197 (1.52%)  2/196 (1.02%) 
Polyneuropathy * 1  0/197 (0.00%)  1/196 (0.51%) 
Presyncope * 1  1/197 (0.51%)  0/196 (0.00%) 
Restless legs syndrome * 1  1/197 (0.51%)  3/196 (1.53%) 
Somnolence * 1  3/197 (1.52%)  2/196 (1.02%) 
Speech disorder * 1  1/197 (0.51%)  0/196 (0.00%) 
Syncope * 1  0/197 (0.00%)  1/196 (0.51%) 
Tension headache * 1  1/197 (0.51%)  0/196 (0.00%) 
Psychiatric disorders     
Affect lability * 1  0/197 (0.00%)  1/196 (0.51%) 
Agitation * 1  1/197 (0.51%)  0/196 (0.00%) 
Anxiety * 1  7/197 (3.55%)  6/196 (3.06%) 
Confusional state * 1  1/197 (0.51%)  0/196 (0.00%) 
Depression * 1  2/197 (1.02%)  3/196 (1.53%) 
Gastrointestinal somatic symptom disorder * 1  0/197 (0.00%)  1/196 (0.51%) 
Insomnia * 1  8/197 (4.06%)  5/196 (2.55%) 
Irritability * 1  1/197 (0.51%)  1/196 (0.51%) 
Panic attack * 1  0/197 (0.00%)  1/196 (0.51%) 
Restlessness * 1  1/197 (0.51%)  0/196 (0.00%) 
Renal and urinary disorders     
Bladder spasm * 1  0/197 (0.00%)  1/196 (0.51%) 
Calculus bladder * 1  1/197 (0.51%)  0/196 (0.00%) 
Dysuria * 1  1/197 (0.51%)  2/196 (1.02%) 
Nocturia * 1  0/197 (0.00%)  1/196 (0.51%) 
Pollakiuria * 1  1/197 (0.51%)  0/196 (0.00%) 
Renal pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Strangury * 1  1/197 (0.51%)  0/196 (0.00%) 
Urinary retention * 1  1/197 (0.51%)  0/196 (0.00%) 
Urinary tract pain * 1  0/197 (0.00%)  1/196 (0.51%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  1/197 (0.51%)  0/196 (0.00%) 
Breast pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Breast tenderness * 1  0/197 (0.00%)  1/196 (0.51%) 
Genital burning sensation * 1  0/197 (0.00%)  1/196 (0.51%) 
Menorrhagia * 1  1/197 (0.51%)  1/196 (0.51%) 
Metrorrhagia * 1  1/197 (0.51%)  0/196 (0.00%) 
Ovarian cyst * 1  1/197 (0.51%)  0/196 (0.00%) 
Pelvic pain * 1  1/197 (0.51%)  1/196 (0.51%) 
Prostatitis * 1  1/197 (0.51%)  0/196 (0.00%) 
Scrotal pain * 1  0/197 (0.00%)  1/196 (0.51%) 
Testicular pain * 1  0/197 (0.00%)  1/196 (0.51%) 
Vaginal haemorrhage * 1  0/197 (0.00%)  3/196 (1.53%) 
Vulvovaginal inflammation * 1  0/197 (0.00%)  1/196 (0.51%) 
Vulvovaginal pain * 1  0/197 (0.00%)  1/196 (0.51%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  1/197 (0.51%)  0/196 (0.00%) 
Cough * 1  11/197 (5.58%)  11/196 (5.61%) 
Dry throat * 1  1/197 (0.51%)  2/196 (1.02%) 
Dysphonia * 1  2/197 (1.02%)  0/196 (0.00%) 
Dyspnoea * 1  8/197 (4.06%)  6/196 (3.06%) 
Dyspnoea exertional * 1  1/197 (0.51%)  0/196 (0.00%) 
Emphysema * 1  1/197 (0.51%)  0/196 (0.00%) 
Epistaxis * 1  1/197 (0.51%)  1/196 (0.51%) 
Hiccups * 1  0/197 (0.00%)  1/196 (0.51%) 
Hyperventilation * 1  0/197 (0.00%)  1/196 (0.51%) 
Laryngeal discomfort * 1  1/197 (0.51%)  0/196 (0.00%) 
Laryngeal inflammation * 1  1/197 (0.51%)  0/196 (0.00%) 
Laryngeal oedema * 1  2/197 (1.02%)  0/196 (0.00%) 
Laryngeal pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Lung disorder * 1  1/197 (0.51%)  0/196 (0.00%) 
Nasal congestion * 1  1/197 (0.51%)  2/196 (1.02%) 
Nasal discomfort * 1  1/197 (0.51%)  1/196 (0.51%) 
Nasal pruritus * 1  1/197 (0.51%)  0/196 (0.00%) 
Oropharyngeal discomfort * 1  1/197 (0.51%)  4/196 (2.04%) 
Oropharyngeal pain * 1  10/197 (5.08%)  2/196 (1.02%) 
Paranasal sinus mucosal hypertrophy * 1  1/197 (0.51%)  1/196 (0.51%) 
Pharyngeal erythema * 1  0/197 (0.00%)  2/196 (1.02%) 
Pharyngeal inflammation * 1  0/197 (0.00%)  1/196 (0.51%) 
Pharyngeal oedema * 1  1/197 (0.51%)  1/196 (0.51%) 
Pharyngeal paraesthesia * 1  1/197 (0.51%)  2/196 (1.02%) 
Productive cough * 1  1/197 (0.51%)  2/196 (1.02%) 
Pulmonary embolism * 1  1/197 (0.51%)  1/196 (0.51%) 
Respiratory disorder * 1  1/197 (0.51%)  1/196 (0.51%) 
Rhinalgia * 1  1/197 (0.51%)  0/196 (0.00%) 
Rhinitis allergic * 1  0/197 (0.00%)  1/196 (0.51%) 
Rhinorrhoea * 1  1/197 (0.51%)  0/196 (0.00%) 
Sleep apnoea syndrome * 1  1/197 (0.51%)  0/196 (0.00%) 
Suffocation feeling * 1  1/197 (0.51%)  0/196 (0.00%) 
Throat tightness * 1  1/197 (0.51%)  0/196 (0.00%) 
Tonsillar disorder * 1  1/197 (0.51%)  0/196 (0.00%) 
Tonsillar erythema * 1  0/197 (0.00%)  1/196 (0.51%) 
Tonsillar hypertrophy * 1  1/197 (0.51%)  0/196 (0.00%) 
Upper respiratory tract inflammation * 1  3/197 (1.52%)  1/196 (0.51%) 
Upper-airway cough syndrome * 1  0/197 (0.00%)  1/196 (0.51%) 
Sinus disorder * 1  0/197 (0.00%)  1/196 (0.51%) 
Sneezing * 1  0/197 (0.00%)  1/196 (0.51%) 
Throat irritation * 1  10/197 (5.08%)  14/196 (7.14%) 
Skin and subcutaneous tissue disorders     
Acne * 1  0/197 (0.00%)  1/196 (0.51%) 
Angioedema * 1  0/197 (0.00%)  1/196 (0.51%) 
Asteatosis * 1  1/197 (0.51%)  0/196 (0.00%) 
Blister * 1  1/197 (0.51%)  0/196 (0.00%) 
Dermatitis * 1  0/197 (0.00%)  1/196 (0.51%) 
Dermatitis allergic * 1  1/197 (0.51%)  0/196 (0.00%) 
Dermatitis contact * 1  1/197 (0.51%)  1/196 (0.51%) 
Drug eruption * 1  1/197 (0.51%)  0/196 (0.00%) 
Dry skin * 1  0/197 (0.00%)  1/196 (0.51%) 
Eczema * 1  3/197 (1.52%)  1/196 (0.51%) 
Erythema * 1  2/197 (1.02%)  7/196 (3.57%) 
Hyperhidrosis * 1  3/197 (1.52%)  2/196 (1.02%) 
Hyperkeratosis * 1  0/197 (0.00%)  1/196 (0.51%) 
Intertrigo * 1  0/197 (0.00%)  1/196 (0.51%) 
Nail disorder * 1  0/197 (0.00%)  1/196 (0.51%) 
Neurodermatitis * 1  1/197 (0.51%)  0/196 (0.00%) 
Night sweats * 1  1/197 (0.51%)  0/196 (0.00%) 
Pruritus allergic * 1  0/197 (0.00%)  1/196 (0.51%) 
Rash * 1  8/197 (4.06%)  10/196 (5.10%) 
Rash erythematous * 1  0/197 (0.00%)  1/196 (0.51%) 
Rash maculo-papular * 1  0/197 (0.00%)  1/196 (0.51%) 
Rash pruritic * 1  0/197 (0.00%)  2/196 (1.02%) 
Scab * 1  0/197 (0.00%)  1/196 (0.51%) 
Seborrhoeic dermatitis * 1  1/197 (0.51%)  0/196 (0.00%) 
Skin burning sensation * 1  1/197 (0.51%)  0/196 (0.00%) 
Skin lesion * 1  2/197 (1.02%)  1/196 (0.51%) 
Swelling face * 1  1/197 (0.51%)  0/196 (0.00%) 
Urticaria * 1  6/197 (3.05%)  3/196 (1.53%) 
Pruritus * 1  22/197 (11.17%)  13/196 (6.63%) 
Pruritus generalised * 1  0/197 (0.00%)  1/196 (0.51%) 
Scar pain * 1  1/197 (0.51%)  0/196 (0.00%) 
Social circumstances     
Menopause * 1  0/106 (0.00%)  1/110 (0.91%) 
Vascular disorders     
Deep vein thrombosis * 1  2/197 (1.02%)  0/196 (0.00%) 
Flushing * 1  4/197 (2.03%)  1/196 (0.51%) 
Hot flush * 1  2/197 (1.02%)  1/196 (0.51%) 
Hypertension * 1  7/197 (3.55%)  5/196 (2.55%) 
Hypotension * 1  1/197 (0.51%)  2/196 (1.02%) 
Lymphoedema * 1  0/197 (0.00%)  1/196 (0.51%) 
Haematoma * 1  0/197 (0.00%)  1/196 (0.51%) 
1
Term from vocabulary, MedDRA (v20.1)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02213263     History of Changes
Other Study ID Numbers: B3281006
2014-000132-41 ( EudraCT Number )
REFLECTIONS ( Other Identifier: Alias Study Number )
First Submitted: August 7, 2014
First Posted: August 11, 2014
Results First Submitted: October 2, 2018
Results First Posted: October 30, 2018
Last Update Posted: June 20, 2019