INHIBITOR: Retrospective Study Of Patients With Renal Cell Carcinoma And Mantle Cell Lymphoma Treated With Temsirolimus
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01367457
Collaborator
(none)
243
16
51
15.2
0.3
Study Details
Study Description
Brief Summary
The principal objective of the study is to evaluate the efficacy and safety of temsirolimus use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
There is not sampling method
Study Design
Study Type:
Observational
Actual Enrollment
:
243 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Inhibitor - Estudio Retrospectivo De Casos Clinicos De Pacientes Con Carcinoma De Celulas Renales Y Con Linforma De Celulas Del Manto Tratados Con Temsirolimus
Study Start Date
:
Jan 1, 2011
Actual Primary Completion Date
:
Apr 1, 2015
Actual Study Completion Date
:
Apr 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients that received treatment with Temsirolimus Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice. |
Other: Temsirolimus (Non-Interventional Study)
There is not any intervention in this study.
|
Outcome Measures
Primary Outcome Measures
- Progression-free Survival (PFS) [From initiation of treatment up to disease progression (up to 80 months)]
Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.
- Percentage of Participants With Objective Response [From initiation of treatment up to disease progression (up to 80 months)]
Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)
- Duration of Response (DOR) [From initiation of treatment up to disease progression (up to 80 months)]
Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2.
- Overall Survival (OS) [From initiation of treatment untill death (up to 80 months)]
Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.
Exclusion Criteria:
Patients that do not have a minimum (pre-specified) of data in their clinical record.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Central de Asturias | Oviedo | Asturias | Spain | 33006 |
| 2 | Hospital de Cabueñes | Cabueñes | Gijon | Spain | 33394 |
| 3 | Hospital Clinico Universitario | Santiago de Compostela | La Coruña | Spain | 15706 |
| 4 | Complejo Hospitalario Materno-Infantil Insular de Las Palmas | Las Palmas de Gran Canaria | Las Palmas | Spain | 35016 |
| 5 | Hospital de Navarra | Pamplona | Navarra | Spain | 31008 |
| 6 | Hospital Provincial de Castellon | Castellon | Valencia | Spain | 12002 |
| 7 | Complexo Hospitalario Universitario A Coruña | A Coruña | Spain | 15006 | |
| 8 | Complejo AAsistencial de Avilla | Avila | Spain | 05004 | |
| 9 | Hospital de La Santa Creu I Sant Pau | Barcelona | Spain | 08025 | |
| 10 | Hospital Vall D'Hebron | Barcelona | Spain | 08035 | |
| 11 | Hospital del Mar | Barcelona | Spain | 8940 | |
| 12 | Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera | La Coruña | Spain | 15006 | |
| 13 | Hospital General Universitario Gregorio Marañon | Madrid | Spain | 28007 | |
| 14 | MD Anderson Cancer Center | Madrid | Spain | 28033 | |
| 15 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
| 16 | Hospital de Madrid Norte - Sanchinarro | Madrid | Spain | 28050 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01367457
Other Study ID Numbers:
- B1771017
- INHIBITOR
First Posted:
Jun 7, 2011
Last Update Posted:
Apr 27, 2016
Last Verified:
Mar 1, 2016
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 243 participants were enrolled in the study, out of which 242 participants received treatment in reporting group "RCC: Temsirolimus", "MCL: Temsirolimus" or "MCL: Temsirolimus + Rituximab" |
| Arm/Group Title | RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab |
|---|---|---|---|
| Arm/Group Description | Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. | Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. |
| Period Title: Overall Study | |||
| STARTED | 193 | 23 | 26 |
| COMPLETED | 5 | 23 | 26 |
| NOT COMPLETED | 188 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. | Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. | Total of all reporting groups |
| Overall Participants | 193 | 23 | 26 | 242 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
65.27
(11.14)
|
70.56
(11.07)
|
72.34
(7.11)
|
66.54
(11.04)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
57
29.5%
|
3
13%
|
3
11.5%
|
63
26%
|
| Male |
136
70.5%
|
20
87%
|
23
88.5%
|
179
74%
|
Outcome Measures
| Title | Progression-free Survival (PFS) |
|---|---|
| Description | Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma. |
| Time Frame | From initiation of treatment up to disease progression (up to 80 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. |
| Arm/Group Title | RCC: Temsirolimus | MCL: Temsirolimus | MCC: Temsirolimus + Rituximab |
|---|---|---|---|
| Arm/Group Description | Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. | Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. |
| Measure Participants | 193 | 23 | 26 |
| Median (95% Confidence Interval) [months] |
4.04
|
7.467
|
13.233
|
| Title | Percentage of Participants With Objective Response |
|---|---|
| Description | Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.) |
| Time Frame | From initiation of treatment up to disease progression (up to 80 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. |
| Arm/Group Title | RCC: Temsirolimus | MCL: Temsirolimus | MCC: Temsirolimus + Rituximab |
|---|---|---|---|
| Arm/Group Description | Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. | Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. |
| Measure Participants | 193 | 23 | 26 |
| CR |
0.5
0.3%
|
34.8
151.3%
|
30.8
118.5%
|
| PR |
14.3
7.4%
|
17.4
75.7%
|
50.0
192.3%
|
| SD |
46.6
24.1%
|
26.1
113.5%
|
7.7
29.6%
|
| DP |
38.6
20%
|
21.7
94.3%
|
11.5
44.2%
|
| Title | Duration of Response (DOR) |
|---|---|
| Description | Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2. |
| Time Frame | From initiation of treatment up to disease progression (up to 80 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | RCC: Temsirolimus | MCL: Temsirolimus | MCC: Temsirolimus + Rituximab |
|---|---|---|---|
| Arm/Group Description | Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. | Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. |
| Measure Participants | 28 | 12 | 20 |
| Median (95% Confidence Interval) [months] |
13.21
|
7.28
|
8.82
|
| Title | Overall Survival (OS) |
|---|---|
| Description | Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive. |
| Time Frame | From initiation of treatment untill death (up to 80 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. |
| Arm/Group Title | RCC: Temsirolimus | MCL: Temsirolimus | MCC: Temsirolimus + Rituximab |
|---|---|---|---|
| Arm/Group Description | Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. | Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. |
| Measure Participants | 193 | 23 | 26 |
| Median (95% Confidence Interval) [months] |
10.81
|
19.233
|
18.667
|
| Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
|---|---|
| Description | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs). |
| Time Frame | Baseline to the 28 calendar days after the last administration of study drug (upto 80 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants with RCC or MCL who received atleast 1 dose of study treatment. |
| Arm/Group Title | RCC: Temsirolimus | MCL: Temsirolimus | MCC: Temsirolimus + Rituximab |
|---|---|---|---|
| Arm/Group Description | Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. | Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. |
| Measure Participants | 193 | 23 | 26 |
| AEs |
145
75.1%
|
19
82.6%
|
16
61.5%
|
| SAEs |
18
9.3%
|
3
13%
|
7
26.9%
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. | |||||
| Arm/Group Title | RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab | |||
| Arm/Group Description | Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study. | Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study. | Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab. | |||
All Cause Mortality |
||||||
| RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 18/193 (9.3%) | 3/23 (13%) | 7/26 (26.9%) | |||
| Blood and lymphatic system disorders | ||||||
| Neutropenia | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Febrile neutropenia | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Cardiac disorders | ||||||
| Atrioventricular block complete | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Cardiac failure congestive | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Gastrointestinal disorders | ||||||
| Stomatitis | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Diarrhoea | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Gastrointestinal toxicity | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| General disorders | ||||||
| Death | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Disease progression | 2/193 (1%) | 0/23 (0%) | 0/26 (0%) | |||
| Malaise | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Pyrexia | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Others | 1/193 (0.5%) | 0/23 (0%) | 2/26 (7.7%) | |||
| Infections and infestations | ||||||
| Herpes zoster | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Aspergillus infection | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Gastroenteritis | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Pneumonia | 0/193 (0%) | 1/23 (4.3%) | 1/26 (3.8%) | |||
| Respiratory tract infection | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Influenza | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Metabolism and nutrition disorders | ||||||
| Hyperglycaemia | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Hyperkalemia | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Haemangioblastoma | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Nervous system disorders | ||||||
| Coma | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Renal and urinary disorders | ||||||
| Renal failure | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pneumonitis | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Chronic obstructive pulmonary disease | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Dyspnoea | 4/193 (2.1%) | 0/23 (0%) | 0/26 (0%) | |||
| Interstitial lung disease | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Vascular disorders | ||||||
| Deep vein thrombosis | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 142/193 (73.6%) | 18/23 (78.3%) | 14/26 (53.8%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 58/193 (30.1%) | 4/23 (17.4%) | 3/26 (11.5%) | |||
| Leukopenia | 2/193 (1%) | 1/23 (4.3%) | 1/26 (3.8%) | |||
| Neutropenia | 4/193 (2.1%) | 1/23 (4.3%) | 3/26 (11.5%) | |||
| Bone marrow toxicity | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Febrile neutropenia | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Lymphopenia | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Thrombocytopenia | 11/193 (5.7%) | 12/23 (52.2%) | 5/26 (19.2%) | |||
| Cardiac disorders | ||||||
| Cardiac failure | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Deafness | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Endocrine disorders | ||||||
| Hypothyroidism | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Eye disorders | ||||||
| Conjunctivitis | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Eyelids pruritus | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Visual acuity reduced | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Gastrointestinal disorders | ||||||
| Stomatitis | 41/193 (21.2%) | 1/23 (4.3%) | 1/26 (3.8%) | |||
| Abdominal pain | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Chronic gastritis | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Constipation | 5/193 (2.6%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Diarrhoea | 13/193 (6.7%) | 3/23 (13%) | 4/26 (15.4%) | |||
| Dyspepsia | 2/193 (1%) | 0/23 (0%) | 0/26 (0%) | |||
| Gastrointestinal haemorrhage | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Haemorrhoids | 1/193 (0.5%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Nausea | 6/193 (3.1%) | 1/23 (4.3%) | 1/26 (3.8%) | |||
| Rectal haemorrhage | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Vomiting | 9/193 (4.7%) | 0/23 (0%) | 0/26 (0%) | |||
| General disorders | ||||||
| Asthenia | 43/193 (22.3%) | 4/23 (17.4%) | 1/26 (3.8%) | |||
| Malaise | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Mucosal inflammation | 3/193 (1.6%) | 2/23 (8.7%) | 1/26 (3.8%) | |||
| Oedema | 3/193 (1.6%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Oedema peripheral | 4/193 (2.1%) | 0/23 (0%) | 0/26 (0%) | |||
| Pain | 3/193 (1.6%) | 0/23 (0%) | 0/26 (0%) | |||
| Pyrexia | 6/193 (3.1%) | 0/23 (0%) | 0/26 (0%) | |||
| Others | 3/193 (1.6%) | 1/23 (4.3%) | 2/26 (7.7%) | |||
| Hepatobiliary disorders | ||||||
| Cholestasis | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Hepatotoxicity | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Immune system disorders | ||||||
| Hypersensitivity | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Infections and infestations | ||||||
| Folliculitis | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Gastrointestinal candidiasis | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Gingivitis | 2/193 (1%) | 0/23 (0%) | 0/26 (0%) | |||
| Infection | 2/193 (1%) | 0/23 (0%) | 0/26 (0%) | |||
| Lung infection | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Nasopharyngitis | 0/193 (0%) | 0/23 (0%) | 2/26 (7.7%) | |||
| Oral candidiasis | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Oral herpes | 0/193 (0%) | 0/23 (0%) | 2/26 (7.7%) | |||
| Respiratory tract infection | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Upper respiratory tract infection | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Urinary tract infection | 1/193 (0.5%) | 1/23 (4.3%) | 2/26 (7.7%) | |||
| Herpes zoster | 2/193 (1%) | 0/23 (0%) | 0/26 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Infusion related reaction | 2/193 (1%) | 0/23 (0%) | 0/26 (0%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 2/193 (1%) | 0/23 (0%) | 0/26 (0%) | |||
| Aspartate aminotransferase increased | 2/193 (1%) | 0/23 (0%) | 0/26 (0%) | |||
| Blood bilirubin increased | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Blood creatinine increased | 6/193 (3.1%) | 0/23 (0%) | 0/26 (0%) | |||
| Transaminases increased | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypercholesterolaemia | 19/193 (9.8%) | 2/23 (8.7%) | 0/26 (0%) | |||
| Hyperglycaemia | 23/193 (11.9%) | 3/23 (13%) | 2/26 (7.7%) | |||
| Hyperlipidaemia | 11/193 (5.7%) | 2/23 (8.7%) | 0/26 (0%) | |||
| Hypophosphataemia | 5/193 (2.6%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Decreased appetite | 13/193 (6.7%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Hyperkalemia | 0/193 (0%) | 0/23 (0%) | 0/26 (0%) | |||
| Hypermagnesaemia | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Hypertriglyceridemia | 8/193 (4.1%) | 2/23 (8.7%) | 0/26 (0%) | |||
| Hypokalaemia | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Hypomagnesaemia | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 2/193 (1%) | 1/23 (4.3%) | 1/26 (3.8%) | |||
| Bursitis | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Groin pain | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Muscle spasms | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Neck pain | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Nervous system disorders | ||||||
| Dizziness | 1/193 (0.5%) | 1/23 (4.3%) | 1/26 (3.8%) | |||
| Dysgeusia | 4/193 (2.1%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Headache | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Neuralgia | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Sciatica | 1/193 (0.5%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Somnolence | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Psychiatric disorders | ||||||
| Confusional state | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Insomnia | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Renal and urinary disorders | ||||||
| Polyuria | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Proteinuria | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Renal failure | 7/193 (3.6%) | 0/23 (0%) | 0/26 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pneumonitis | 17/193 (8.8%) | 2/23 (8.7%) | 2/26 (7.7%) | |||
| Cough | 0/193 (0%) | 1/23 (4.3%) | 1/26 (3.8%) | |||
| Dyspnoea | 4/193 (2.1%) | 0/23 (0%) | 0/26 (0%) | |||
| Epistaxis | 2/193 (1%) | 0/23 (0%) | 0/26 (0%) | |||
| Pleural effusion | 2/193 (1%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Tonsillar disorder | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dry skin | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Skin toxicity | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Alopecia | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Angioedema | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Dermal toxicity | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Eczema | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Hyperhidrosis | 1/193 (0.5%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Nail disorder | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Nail toxicity | 5/193 (2.6%) | 0/23 (0%) | 0/26 (0%) | |||
| Pruritus | 5/193 (2.6%) | 0/23 (0%) | 0/26 (0%) | |||
| Pruritus generalised | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Rash | 26/193 (13.5%) | 2/23 (8.7%) | 3/26 (11.5%) | |||
| Skin mass | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Urticaria | 1/193 (0.5%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Vascular disorders | ||||||
| Aortic aneurysm | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Deep vein thrombosis | 1/193 (0.5%) | 0/23 (0%) | 0/26 (0%) | |||
| Embolism | 0/193 (0%) | 1/23 (4.3%) | 0/26 (0%) | |||
| Hypotension | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
| Thrombophlebitis | 0/193 (0%) | 0/23 (0%) | 1/26 (3.8%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 | 800-718-1021 ext 001 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01367457
Other Study ID Numbers:
- B1771017
- INHIBITOR
First Posted:
Jun 7, 2011
Last Update Posted:
Apr 27, 2016
Last Verified:
Mar 1, 2016