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Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01180049
Recruitment Status : Completed
First Posted : August 11, 2010
Results First Posted : May 19, 2017
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Hodgkin's Lymphoma
Intervention Drug: temsirolimus
Enrollment 101
Recruitment Details The study was conducted at multiple centers from 10 Mar 2011 to 28 Jun 2018.
Pre-assignment Details  
Arm/Group Title TEMSR 175/75 mg TEMSR 75 mg
Hide Arm/Group Description Participants had received desipramine 50 milligrams (mg) one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter. Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
Period Title: Overall Study
Started 53 48
Completed 0 0
Not Completed 53 48
Reason Not Completed
Other             9             7
Lost to Follow-up             8             6
Death             36             35
Arm/Group Title TEMSR 175/75 mg TEMSR 75 mg Total
Hide Arm/Group Description Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter. Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly. Total of all reporting groups
Overall Number of Baseline Participants 53 48 101
Hide Baseline Analysis Population Description
The analysis was done on Intent-to-Treat (ITT) Population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 48 participants 101 participants
67.2  (9.11) 66.3  (8.36) 66.8  (8.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 48 participants 101 participants
Female
15
  28.3%
8
  16.7%
23
  22.8%
Male
38
  71.7%
40
  83.3%
78
  77.2%
1.Primary Outcome
Title Independently Assessed Progression-free Survival (PFS)
Hide Description

PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.

PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.

PFS assessment was done using EMA guidelines for sensitivity analysis censoring.

Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment.

Time Frame From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.
Arm/Group Title TEMSR 175/75 mg TEMSR 75 mg
Hide Arm/Group Description:
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
Overall Number of Participants Analyzed 47 43
Median (80% Confidence Interval)
Unit of Measure: Months
4.3
(3.3 to 6.4)
4.5
(2.7 to 4.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TEMSR 175/75 mg, TEMSR 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.731
Confidence Interval (2-Sided) 80%
0.520 to 1.027
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from the date of randomization to the date of death due to any cause.
Time Frame From randomization date until death due to any cause (average follow up done for 56.1 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on ITT population. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Arm/Group Title TEMSR 175/75 mg TEMSR 75 mg
Hide Arm/Group Description:
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
Overall Number of Participants Analyzed 53 48
Median (80% Confidence Interval)
Unit of Measure: Months
10.9
(7.0 to 19.7)
11.2
(6.6 to 18.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TEMSR 175/75 mg, TEMSR 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.778
Confidence Interval (2-Sided) 80%
0.568 to 1.064
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Independent Assessment - Objective Response Rate (ORR = CR + PR)
Hide Description

ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.

Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR.

Time Frame From randomization date until end of treatment (average follow up done for 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.
Arm/Group Title TEMSR 175/75 mg TEMSR 75 mg
Hide Arm/Group Description:
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
Overall Number of Participants Analyzed 47 43
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: Percentage of participants
27.7
(19.1 to 37.7)
20.9
(13.0 to 31.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TEMSR 175/75 mg, TEMSR 75 mg
Comments Independent assessment- Difference (%) TEMSR 175/75 mg – TEMSR 75 mg (80% CI)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in arms
Estimated Value 6.7
Confidence Interval (2-Sided) 80%
-6.9 to 20.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Investigator's Assessment ORR (ORR = CR + PR)
Hide Description

ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.

Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR.

Time Frame From randomization date until end of treatment (average follow up done for 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.
Arm/Group Title TEMSR 175/75 mg TEMSR 75 mg
Hide Arm/Group Description:
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
Overall Number of Participants Analyzed 47 43
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: Percentage of participants
31.9
(22.9 to 42.2)
18.6
(11.1 to 28.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TEMSR 175/75 mg, TEMSR 75 mg
Comments Investigator’s assessment- Difference (%)TEMSR 175/75 mg – TEMSR 75 mg (80% CI)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference between arms
Estimated Value 13.3
Confidence Interval (2-Sided) 80%
-0.4 to 26.7
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Investigator Assessed PFS
Hide Description

PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.

PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.

PFS assessment was done using EMA guidelines for sensitivity analysis censoring.

Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment.

Time Frame From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.
Arm/Group Title TEMSR 175/75 mg TEMSR 75 mg
Hide Arm/Group Description:
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
Overall Number of Participants Analyzed 47 43
Median (80% Confidence Interval)
Unit of Measure: Months
4.7
(2.7 to 8.3)
3.9
(2.8 to 4.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TEMSR 175/75 mg, TEMSR 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.646
Confidence Interval (2-Sided) 80%
0.453 to 0.922
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Hide Description An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. Treatment-emergent infection-related AEs included events: pneumonia, bronchitis, infection, herpes simplex, oral candidiasis and sepsis. Grading by NCI CTCAE Version 3.0.: Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening; urgent intervention indicated; Grade 5= death.
Time Frame From screening up to a maximum of 57.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR was included in the evaluation for safety.
Arm/Group Title TEMSR 175/75 mg TEMSR 75 mg
Hide Arm/Group Description:
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Percentage of participants
Pneumonia 17.0 21.3
Bronchitis 7.5 2.1
Infection 5.7 2.1
Herpes simplex 3.8 2.1
Oral candidiasis 3.8 0
Cellulitis 1.9 0
Sepsis 0 2.1
7.Secondary Outcome
Title Percentage of Participants With Treatment-Emergent Bleeding-Related AEs With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Hide Description An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. Treatment-emergent bleeding related AEs included events: epistaxis and ecchymosis. AE were assessed according to maximum severity grading based on NCI CTCAE Version 4.03.Grade 1=mild; Grade 2=moderate; within normal limits. Grade 3=severe or medically significant but not immediately life-threatening; Grade 4=life-threatening or disabling; urgent intervention indicated; Grade 5=death.
Time Frame From screening up to a maximum of 57.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR was included in the evaluation for safety.
Arm/Group Title TEMSR 175/75 mg TEMSR 75 mg
Hide Arm/Group Description:
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Percentage of participants
Epistaxis 13.2 2.1
Ecchymosis 1.9 0
8.Secondary Outcome
Title Quantify the Potential Effect of TEMSR on AUC and Cmax
Hide Description

Potential TEMSR effects were investigated by calculating the ratio of AUCs with and without concomitant TEMSR from the model-estimated effect of TEMSR on apparent clearance (CL/F) values and using individual ratios of observed Cmax values with and without concomitant temsirolimus, for both parent and metabolite. The AUC mean ratio was calculated as 1 / mean shift on apparent clearance from TEMSR, and the 90% CI of the AUC ratios was calculated as 1 / 90% CI of the shift on apparent clearance from TEMSR.

AUC: Area under plasma concentration-time curve from time zero to infinity Cmax: Characterization of maximum observed plasma concentration

Time Frame From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on ITT Population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.
Arm/Group Title TEMSR 175/75 mg TEMSR 75 mg
Hide Arm/Group Description:
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
Overall Number of Participants Analyzed 47 43
Mean (90% Confidence Interval)
Unit of Measure: Ratio
AUC
1.00
(0.965 to 1.11)
0.980
(0.870 to 1.12)
Cmax
0.828
(0.758 to 0.898)
0.779
(0.7005 to 0.857)
Time Frame From screening up to a maximum of 57.1 months
Adverse Event Reporting Description Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
 
Arm/Group Title TEMSR 175/75 mg TEMSR 75 mg
Hide Arm/Group Description Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter. Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
All-Cause Mortality
TEMSR 175/75 mg TEMSR 75 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
TEMSR 175/75 mg TEMSR 75 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   35/53 (66.04%)   34/47 (72.34%) 
Blood and lymphatic system disorders     
Agranulocytosis * 1  1/53 (1.89%)  0/47 (0.00%) 
Anaemia * 1  2/53 (3.77%)  1/47 (2.13%) 
Febrile neutropenia * 1  1/53 (1.89%)  0/47 (0.00%) 
Thrombocytopenia * 1  1/53 (1.89%)  2/47 (4.26%) 
Cardiac disorders     
Cardiac failure * 1  0/53 (0.00%)  2/47 (4.26%) 
Cardiopulmonary failure * 1  0/53 (0.00%)  1/47 (2.13%) 
Myocardial infarction * 1  1/53 (1.89%)  0/47 (0.00%) 
Atrial fibrillation * 1  2/53 (3.77%)  0/47 (0.00%) 
Endocrine disorders     
Hyperthyroidism * 1  0/53 (0.00%)  1/47 (2.13%) 
Eye disorders     
Cataract * 1  1/53 (1.89%)  0/47 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/53 (1.89%)  0/47 (0.00%) 
Acute abdomen * 1  0/53 (0.00%)  1/47 (2.13%) 
Ascites * 1  0/53 (0.00%)  1/47 (2.13%) 
Diarrhoea * 1  0/53 (0.00%)  1/47 (2.13%) 
Gastric disorder * 1  1/53 (1.89%)  0/47 (0.00%) 
Gastric ulcer * 1  1/53 (1.89%)  0/47 (0.00%) 
Incarcerated inguinal hernia * 1  0/53 (0.00%)  1/47 (2.13%) 
Rectal haemorrhage * 1  0/53 (0.00%)  1/47 (2.13%) 
Vomiting * 1  0/53 (0.00%)  1/47 (2.13%) 
Colitis * 1  1/53 (1.89%)  0/47 (0.00%) 
Colitis ulcerative * 1  1/53 (1.89%)  0/47 (0.00%) 
Gastric perforation * 1  1/53 (1.89%)  0/47 (0.00%) 
General disorders     
Death * 1  0/53 (0.00%)  1/47 (2.13%) 
Disease progression * 1  10/53 (18.87%)  9/47 (19.15%) 
Mucosal inflammation * 1  0/53 (0.00%)  1/47 (2.13%) 
Multiple organ dysfunction syndrome * 1  1/53 (1.89%)  0/47 (0.00%) 
Pyrexia * 1  4/53 (7.55%)  1/47 (2.13%) 
Infections and infestations     
Bronchitis * 1  1/53 (1.89%)  0/47 (0.00%) 
Device related infection * 1  2/53 (3.77%)  0/47 (0.00%) 
Fungal infection * 1  0/53 (0.00%)  1/47 (2.13%) 
Infection * 1  1/53 (1.89%)  0/47 (0.00%) 
Influenza * 1  1/53 (1.89%)  0/47 (0.00%) 
Listeria sepsis * 1  0/53 (0.00%)  1/47 (2.13%) 
Pneumocystis jirovecii pneumonia * 1  1/53 (1.89%)  0/47 (0.00%) 
Pneumonia * 1  7/53 (13.21%)  9/47 (19.15%) 
Pneumonia pseudomonal * 1  1/53 (1.89%)  0/47 (0.00%) 
Pneumonia streptococcal * 1  0/53 (0.00%)  1/47 (2.13%) 
Sepsis * 1  0/53 (0.00%)  1/47 (2.13%) 
Sinusitis * 1  2/53 (3.77%)  0/47 (0.00%) 
Upper respiratory tract infection * 1  1/53 (1.89%)  2/47 (4.26%) 
Varicella zoster virus infection * 1  0/53 (0.00%)  1/47 (2.13%) 
Viral skin infection * 1  1/53 (1.89%)  0/47 (0.00%) 
Cellulitis * 1  1/53 (1.89%)  0/47 (0.00%) 
Gastroenteritis * 1  1/53 (1.89%)  0/47 (0.00%) 
Atypical pneumonia * 1  1/53 (1.89%)  0/47 (0.00%) 
Injury, poisoning and procedural complications     
Toxicity to various agents * 1  0/53 (0.00%)  1/47 (2.13%) 
Joint dislocation * 1  0/53 (0.00%)  1/47 (2.13%) 
Wound dehiscence * 1  1/53 (1.89%)  0/47 (0.00%) 
Investigations     
Eastern Cooperative Oncology Group performance status worsened * 1  0/53 (0.00%)  1/47 (2.13%) 
Haemoglobin * 1  1/53 (1.89%)  0/47 (0.00%) 
Streptococcus test positive * 1  0/53 (0.00%)  1/47 (2.13%) 
Alanine aminotransferase increased * 1  1/53 (1.89%)  0/47 (0.00%) 
Aspartate aminotransferase increased * 1  1/53 (1.89%)  0/47 (0.00%) 
Human rhinovirus test positive * 1  0/53 (0.00%)  1/47 (2.13%) 
Metabolism and nutrition disorders     
Acidosis * 1  0/53 (0.00%)  1/47 (2.13%) 
Decreased appetite * 1  1/53 (1.89%)  0/47 (0.00%) 
Hyperglycaemia * 1  4/53 (7.55%)  5/47 (10.64%) 
Hypertriglyceridaemia * 1  0/53 (0.00%)  1/47 (2.13%) 
Hypoglycaemia * 1  1/53 (1.89%)  0/47 (0.00%) 
Hypophosphataemia * 1  0/53 (0.00%)  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders     
Chondrocalcinosis pyrophosphate * 1  0/53 (0.00%)  1/47 (2.13%) 
Nervous system disorders     
Headache * 1  0/53 (0.00%)  1/47 (2.13%) 
Presyncope * 1  0/53 (0.00%)  1/47 (2.13%) 
Psychiatric disorders     
Hallucination * 1  1/53 (1.89%)  0/47 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/53 (1.89%)  0/47 (0.00%) 
Epistaxis * 1  1/53 (1.89%)  0/47 (0.00%) 
Hiccups * 1  1/53 (1.89%)  0/47 (0.00%) 
Interstitial lung disease * 1  2/53 (3.77%)  3/47 (6.38%) 
Pleural effusion * 1  0/53 (0.00%)  2/47 (4.26%) 
Pneumonitis * 1  1/53 (1.89%)  2/47 (4.26%) 
Pulmonary embolism * 1  0/53 (0.00%)  1/47 (2.13%) 
Respiratory failure * 1  1/53 (1.89%)  0/47 (0.00%) 
Acute pulmonary oedema * 1  1/53 (1.89%)  0/47 (0.00%) 
Pulmonary fibrosis * 1  1/53 (1.89%)  1/47 (2.13%) 
Skin and subcutaneous tissue disorders     
Skin ulcer * 1  0/53 (0.00%)  1/47 (2.13%) 
Vascular disorders     
Circulatory collapse * 1  0/53 (0.00%)  1/47 (2.13%) 
Thrombophlebitis * 1  0/53 (0.00%)  1/47 (2.13%) 
Thrombosis * 1  0/53 (0.00%)  1/47 (2.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v21.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TEMSR 175/75 mg TEMSR 75 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   51/53 (96.23%)   46/47 (97.87%) 
Blood and lymphatic system disorders     
Anaemia * 1  14/53 (26.42%)  13/47 (27.66%) 
Leukopenia * 1  5/53 (9.43%)  2/47 (4.26%) 
Neutropenia * 1  18/53 (33.96%)  11/47 (23.40%) 
Thrombocytopenia * 1  37/53 (69.81%)  28/47 (59.57%) 
Leukocytosis * 1  3/53 (5.66%)  1/47 (2.13%) 
Lymphadenopathy * 1  3/53 (5.66%)  1/47 (2.13%) 
Lymphopenia * 1  2/53 (3.77%)  3/47 (6.38%) 
Cardiac disorders     
Tachycardia * 1  0/53 (0.00%)  4/47 (8.51%) 
Eye disorders     
Dry eye * 1  0/53 (0.00%)  3/47 (6.38%) 
Gastrointestinal disorders     
Abdominal pain * 1  3/53 (5.66%)  6/47 (12.77%) 
Constipation * 1  6/53 (11.32%)  5/47 (10.64%) 
Diarrhoea * 1  19/53 (35.85%)  14/47 (29.79%) 
Mouth ulceration * 1  3/53 (5.66%)  3/47 (6.38%) 
Nausea * 1  6/53 (11.32%)  9/47 (19.15%) 
Stomatitis * 1  7/53 (13.21%)  4/47 (8.51%) 
Vomiting * 1  2/53 (3.77%)  3/47 (6.38%) 
Aphthous ulcer * 1  1/53 (1.89%)  4/47 (8.51%) 
General disorders     
Asthenia * 1  7/53 (13.21%)  7/47 (14.89%) 
Chest discomfort * 1  1/53 (1.89%)  4/47 (8.51%) 
Fatigue * 1  11/53 (20.75%)  13/47 (27.66%) 
Oedema peripheral * 1  9/53 (16.98%)  8/47 (17.02%) 
Pyrexia * 1  13/53 (24.53%)  11/47 (23.40%) 
Mucosal inflammation * 1  3/53 (5.66%)  5/47 (10.64%) 
Infections and infestations     
Bronchitis * 1  4/53 (7.55%)  1/47 (2.13%) 
Herpes simplex * 1  4/53 (7.55%)  2/47 (4.26%) 
Infection * 1  3/53 (5.66%)  1/47 (2.13%) 
Nasopharyngitis * 1  3/53 (5.66%)  1/47 (2.13%) 
Pneumonia * 1  3/53 (5.66%)  4/47 (8.51%) 
Rhinitis * 1  4/53 (7.55%)  1/47 (2.13%) 
Skin infection * 1  3/53 (5.66%)  1/47 (2.13%) 
Upper respiratory tract infection * 1  10/53 (18.87%)  10/47 (21.28%) 
Urinary tract infection * 1  3/53 (5.66%)  3/47 (6.38%) 
Oral candidiasis * 1  3/53 (5.66%)  2/47 (4.26%) 
Injury, poisoning and procedural complications     
Contusion * 1  0/53 (0.00%)  3/47 (6.38%) 
Investigations     
Blood pressure increased * 1  3/53 (5.66%)  0/47 (0.00%) 
Platelet count decreased * 1  6/53 (11.32%)  2/47 (4.26%) 
Weight decreased * 1  6/53 (11.32%)  6/47 (12.77%) 
Blood cholesterol increased * 1  3/53 (5.66%)  0/47 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  6/53 (11.32%)  8/47 (17.02%) 
Diabetes mellitus * 1  2/53 (3.77%)  5/47 (10.64%) 
Hypercholesterolaemia * 1  3/53 (5.66%)  5/47 (10.64%) 
Hyperglycaemia * 1  4/53 (7.55%)  5/47 (10.64%) 
Hypertriglyceridaemia * 1  6/53 (11.32%)  5/47 (10.64%) 
Hypoalbuminaemia * 1  2/53 (3.77%)  4/47 (8.51%) 
Hypokalaemia * 1  8/53 (15.09%)  8/47 (17.02%) 
Hypophosphataemia * 1  3/53 (5.66%)  3/47 (6.38%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/53 (5.66%)  1/47 (2.13%) 
Pain in extremity * 1  1/53 (1.89%)  3/47 (6.38%) 
Nervous system disorders     
Dysgeusia * 1  2/53 (3.77%)  4/47 (8.51%) 
Headache * 1  5/53 (9.43%)  3/47 (6.38%) 
Psychiatric disorders     
Initial insomnia * 1  0/53 (0.00%)  3/47 (6.38%) 
Insomnia * 1  4/53 (7.55%)  0/47 (0.00%) 
Renal and urinary disorders     
Pollakiuria * 1  3/53 (5.66%)  0/47 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  8/53 (15.09%)  9/47 (19.15%) 
Dyspnoea * 1  10/53 (18.87%)  13/47 (27.66%) 
Dyspnoea exertional * 1  3/53 (5.66%)  5/47 (10.64%) 
Epistaxis * 1  14/53 (26.42%)  9/47 (19.15%) 
Oropharyngeal pain * 1  1/53 (1.89%)  3/47 (6.38%) 
Pneumonitis * 1  4/53 (7.55%)  2/47 (4.26%) 
Skin and subcutaneous tissue disorders     
Eczema * 1  5/53 (9.43%)  5/47 (10.64%) 
Erythema * 1  0/53 (0.00%)  4/47 (8.51%) 
Night sweats * 1  0/53 (0.00%)  5/47 (10.64%) 
Onychoclasis * 1  4/53 (7.55%)  1/47 (2.13%) 
Pruritus * 1  3/53 (5.66%)  3/47 (6.38%) 
Rash * 1  10/53 (18.87%)  8/47 (17.02%) 
Skin lesion * 1  1/53 (1.89%)  3/47 (6.38%) 
Vascular disorders     
Hypertension * 1  3/53 (5.66%)  0/47 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v21.0
Overall Survival was not collected for the intended duration as planned initially, no long term follow up was conducted according to amendment in protocol. Hence overall survival results were limited
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01180049    
Other Study ID Numbers: 3066K1-4438
B1771007 ( Other Identifier: Alias Study Number )
2009-015498-11 ( EudraCT Number )
First Submitted: August 9, 2010
First Posted: August 11, 2010
Results First Submitted: November 4, 2016
Results First Posted: May 19, 2017
Last Update Posted: May 20, 2019