Study Evaluating Biomarkers In Relapsed/Refractory Pediat... | NCT00106353 | Trialant
NCT00106353
Sponsor
Pfizer
Status
Completed
Last Update Posted
Feb 8, 2013Estimated
Enrollment
71Actual
Phase
Phase 1Phase 2
Conditions
Adenocarcinoma
Neoplasms
Interventions
Torisel
Countries
United States
Canada
France
Germany
Mexico
Poland
Russia
Protocol Section
Identification Module
NCT ID
NCT00106353
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3066K1-139
Secondary IDs
Not provided
Brief Title
Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors
Official Title
A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2005
Primary Completion Date
Oct 2009Actual
Completion Date
Jan 2012Actual
First Submitted Date
Mar 22, 2005
First Submission Date that Met QC Criteria
Mar 22, 2005
First Posted Date
Mar 23, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 5, 2010
Results First Submitted that Met QC Criteria
Dec 10, 2010
Results First Posted Date
Jan 11, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 4, 2013
Last Update Posted Date
Feb 8, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors.
Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)
Detailed Description
Not provided
Conditions Module
Conditions
Adenocarcinoma
Neoplasms
Keywords
Pediatric Tumors
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
71Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1.0
Experimental
Drug: Torisel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Torisel
Drug
60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1
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.
Baseline up to End of Treatment (EOT) (within 30 days of last dose)
Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 1
TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period.
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 1
TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period. National Cancer Institute (NCI)-graded Common Toxicity Criteria (CTC) provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).
Baseline up to EOT (within 30 days of last dose)
Number of Participants Who Died: Part 1
Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Who Reached Maximum Tolerated Dose Due to Dose Limiting Toxicity: Part 1
Maximum tolerated dose (MTD) defined as the dose level at which >=2 of 3 participants or >=2 of 6 participants if the dose level had been expanded, experienced a dose limiting toxicity (DLT) by day 21 after the first dose of study treatment. DLT defined as failure to recover to NCI-CTCAE version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of > 3 weeks) unless the investigator and the medical monitor agree that the subject should remain in the study.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
Part 1 only:
- Subjects with a histological diagnosis of advanced cancer (solid tumors or central nervous system [CNS] tumors) with disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available (histological confirmation waived for brain stem gliomas and optic pathway tumors)
Part 2 only:
Subjects with histologically confirmed diagnosis of refractory or relapsed: Neuroblastoma, High-grade gliomas: glioblastoma multiforme, anaplastic astrocytomas, and other high-grade gliomas (histological confirmation waived for brain stem gliomas), Rhabdomyosarcoma.
Measurable disease (for subjects with neuroblastoma, evaluable disease as determined by a positive metaiodobenzylguanidine (MIBG) scan will also be permitted).
Geoerger B, Kieran MW, Grupp S, Perek D, Clancy J, Krygowski M, Ananthakrishnan R, Boni JP, Berkenblit A, Spunt SL. Phase II trial of temsirolimus in children with high-grade glioma, neuroblastoma and rhabdomyosarcoma. Eur J Cancer. 2012 Jan;48(2):253-62. doi: 10.1016/j.ejca.2011.09.021. Epub 2011 Oct 25.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligram per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
FG001
Temsirolimus 25 mg/m^2: Part 1
Periods
Title
Milestones
Reasons Not Completed
Part 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
1.0
temsirolimus
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 1
SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability / incapacity or are a congenital anomaly or birth defect in the offspring of a study subject. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 1
Temporary interruption of study treatment; may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 1
Dose reduction for individual participant allowed if a dose limiting toxicity (DLT) occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 1
Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees Celsius (C), respiratory rate >20 beats per minute (bpm), and systolic and diastolic blood pressure (BP) >200/110 millimeters of mercury (mmHg). Participants may be reported in more than 1 category.
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 1
Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.
Baseline up to EOT (within 30 days of last dose)
Percentage of Participants With Objective Response (OR) at Week 12: Part 2
Measured as Complete response (CR), Very good partial response (VGPR), or Partial response (PR) on at least 2 occasions greater than or equal to (>=) 4 weeks apart within first 12 weeks. CR=disappearance of all primary and metastatic lesions; Homovanillic acid, Vanillymandelic acid (HVA/VMA) normal; bone marrow immunocytology negative. VGPR=disappearance of all metastatic lesions (residual areas of uptake on bone permitted); 90 to 99 percent (%) decrease in primary disease measurement; HVA/VMA normal or both decreased >90%. PR=at least 50% decrease in primary and metastatic disease. Number of bone sites decreased by at least 50%.
Week 12
Baseline up to Month 6
Maximum Observed Plasma Concentration (Cmax): Part 1
0 (pre-dose), 1, 2, 6, 24, and 168 hours (hrs) post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 1
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Plasma Decay Half-Life (t1/2): Part 1
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 1
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Area Under the Concentration-Time Curve (AUC): Part 1
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Clearance (CL): Part 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Volume of Distribution at Steady State (Vss): Part 1
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Percentage of Participants With Best Overall Response: Part 1
Best overall response is the best response recorded from baseline until disease progression or recurrence. Measured as CR, PR, SD, PD, or Unknown. CR=disappearance of all primary and metastatic lesions. PR=at least a 50% decrease in primary disease measurement. SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=any new lesion; at least a 25% increase in any disease measurement (reference smallest disease measurement recorded since start of treatment); or appearance of 1 or more new lesions. Tumor response considered Unknown if assessment prior to Day 37.
Baseline until disease progression or recurrence (actual greatest response day is up to Day 49)
Percentage of Participants Exhibiting Freedom From Progression at Week 12: Part 2
Freedom from progression measured as Stable Disease (SD) or better and no Progressive Disease (PD); (CR+VGPR+Mixed Response [MR]+PR+SD). CR=disappearance of all primary and metastatic lesions. VGPR=disappearance of all metastatic lesions. MR=no new lesions; at least 50% decrease in any 1 disease measurement with <50% decrease in any other disease measurement or an increase of <25% in any lesion). SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=at least a 25% increase in any disease measurement; or the appearance of 1 or more new lesions.
Week 12
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 2
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.
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 2
Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 2
Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).
Baseline up to EOT (within 30 days of last dose)
Number of Participants Who Died: Part 2
Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 2
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. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Temporary interruption of study treatment may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 2
Dose reduction for individual participant allowed if a DLT occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 2
Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees C, respiratory rate >20 bpm, and systolic and diastolic BP >200/110 mmHg. Participants may be reported in more than 1 category.
Baseline up to EOT (within 30 days of last dose)
Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 2
Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.
Baseline up to EOT (within 30 days of last dose)
Maximum Observed Plasma Concentration (Cmax): Part 2
0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Average Plasma Concentration (Cavg): Part 2
0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 2
0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Plasma Decay Half-Life (t1/2): Part 2
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 2
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Area Under the Concentration-time Curve at Steady State (AUCss): Part 2
AUCss is a measure of the serum concentration of the drug at steady state. It is used to characterize drug absorption.
0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Clearance (CL): Part 2
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Concentration in Plasma (Cp) and Concentration in Plasma at Time Zero (Cp Time 0): Part 1 and Part 2
Pharmacokinetic parameters determined in whole blood; derived from the concentration-versus-time profiles using noncompartmental analysis method. Measured as nanograms per milliliter (ng/mL).
Part 1: 0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2; Part2: 0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
Number of Participants for Change From Baseline in the Phosphorylation of Mammalian Target of Rapamycin (mTOR) Pathway Proteins: Part 1 and Part 2
Optional bone marrow sampling for pharmacodynamic analysis of effects of study treatment. Data may not be collected for a majority of patients and was not to be summarized if collection was sparse.
Part 1:Baseline,1,2,6,24,168 hrs post-dose of Cycle 1;additional 0 (Pre-dose),24,72,96 hrs, Day 16 to 21 of cycle 2, EOT(within 30 days of last dose); Part 2:Baseline,Day16 to 21 in Cycle 2, at time of disease progression, EOT(within 30 days of last dose)
San Francisco
California
94143
United States
Pfizer Investigational Site
Chicago
Illinois
60614
United States
Pfizer Investigational Site
Indianapolis
Indiana
46202
United States
Pfizer Investigational Site
Boston
Massachusetts
02115
United States
Pfizer Investigational Site
New York
New York
10032
United States
Pfizer Investigational Site
New York
New York
11021
United States
Pfizer Investigational Site
Philadelphia
Pennsylvania
19104-4318
United States
Pfizer Investigational Site
Philadelphia
Pennsylvania
19104
United States
Pfizer Investigational Site
Greenville
South Carolina
29605
United States
Pfizer Investigational Site
Memphis
Tennessee
38105-2794
United States
Pfizer Investigational Site
Houston
Texas
77030-2399
United States
Pfizer Investigational Site
Houston
Texas
77030
United States
Pfizer Investigational Site
Seattle
Washington
98105
United States
Pfizer Investigational Site
Calgary
Alberta
T3B 6A8
Canada
Pfizer Investigational Site
Edmonton
Alberta
T6G 2B7
Canada
Pfizer Investigational Site
Vancouver
British Columbia
V6H 3V4
Canada
Pfizer Investigational Site
Halifax
Nova Scotia
B3K 6R8
Canada
Pfizer Investigational Site
London
Ontario
N6A 4G5
Canada
Pfizer Investigational Site
Toronto
Ontario
M5G 1X8
Canada
Pfizer Investigational Site
Paris
75248
France
Pfizer Investigational Site
Villejuif
94805
France
Pfizer Investigational Site
Münster
48149
Germany
Pfizer Investigational Site
Mexico City
Mexico City
04530
Mexico
Pfizer Investigational Site
Lublin
20- 093
Poland
Pfizer Investigational Site
Lublin
20-093
Poland
Pfizer Investigational Site
Warsaw
04-730
Poland
Pfizer Investigational Site
Moscow
115478
Russia
Pfizer Investigational Site
Moscow
117513
Russia
Pfizer Investigational Site
Saint Petersburg
197110
Russia
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
FG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
FG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
FG004
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
FG005
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
FG006
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
FG0004 subjects
FG0015 subjects
FG0023 subjects
FG0037 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0004 subjects
FG0015 subjects
FG0023 subjects
FG0037 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Disease progression
FG0003 subjects
FG0014 subjects
FG0021 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Symptomatic deterioration
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Entered follow-up phase
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Part 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00417 subjects
FG00519 subjects
FG00616 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Disease progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1
Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
BG001
Part 2
Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00019
BG00152
BG00271
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
Greater than or equal to(>=)1 to less than16 years
Title
Measurements
BG00012
BG00142
BG00254
>=16 to less than 18 years
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG00117
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1
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.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to End of Treatment (EOT) (within 30 days of last dose)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG0004
OG0015
OG0023
OG003
Secondary
Number of Participants Who Reached Maximum Tolerated Dose Due to Dose Limiting Toxicity: Part 1
Maximum tolerated dose (MTD) defined as the dose level at which >=2 of 3 participants or >=2 of 6 participants if the dose level had been expanded, experienced a dose limiting toxicity (DLT) by day 21 after the first dose of study treatment. DLT defined as failure to recover to NCI-CTCAE version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of > 3 weeks) unless the investigator and the medical monitor agree that the subject should remain in the study.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to Month 6
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Secondary
Maximum Observed Plasma Concentration (Cmax): Part 1
Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/mL)
0 (pre-dose), 1, 2, 6, 24, and 168 hours (hrs) post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 1
Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.
Posted
Mean
Standard Deviation
hr
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Secondary
Plasma Decay Half-Life (t1/2): Part 1
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.
Posted
Mean
Standard Deviation
hr
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 1
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).
Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.
Posted
Mean
Standard Deviation
hr*ng/mL
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG003
Secondary
Area Under the Concentration-Time Curve (AUC): Part 1
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.
Posted
Mean
Standard Deviation
hr*ng/mL
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Secondary
Clearance (CL): Part 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.
Posted
Mean
Standard Deviation
Liter/hr
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Secondary
Volume of Distribution at Steady State (Vss): Part 1
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.
Posted
Mean
Standard Deviation
Liter
0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Secondary
Percentage of Participants With Best Overall Response: Part 1
Best overall response is the best response recorded from baseline until disease progression or recurrence. Measured as CR, PR, SD, PD, or Unknown. CR=disappearance of all primary and metastatic lesions. PR=at least a 50% decrease in primary disease measurement. SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=any new lesion; at least a 25% increase in any disease measurement (reference smallest disease measurement recorded since start of treatment); or appearance of 1 or more new lesions. Tumor response considered Unknown if assessment prior to Day 37.
Efficacy evaluable population included all participants who received at least 3 doses of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.
Posted
Number
percentage of participants
Baseline until disease progression or recurrence (actual greatest response day is up to Day 49)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Secondary
Percentage of Participants Exhibiting Freedom From Progression at Week 12: Part 2
Freedom from progression measured as Stable Disease (SD) or better and no Progressive Disease (PD); (CR+VGPR+Mixed Response [MR]+PR+SD). CR=disappearance of all primary and metastatic lesions. VGPR=disappearance of all metastatic lesions. MR=no new lesions; at least 50% decrease in any 1 disease measurement with <50% decrease in any other disease measurement or an increase of <25% in any lesion). SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=at least a 25% increase in any disease measurement; or the appearance of 1 or more new lesions.
Efficacy evaluable population included all participants who received at least 3 doses of study treatment. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG001
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG002
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 2
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.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG001
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG002
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Secondary
Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 2
Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG001
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG002
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Secondary
Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 2
Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG001
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG002
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Secondary
Number of Participants Who Died: Part 2
Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG001
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG002
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Units
Secondary
Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 2
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. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG001
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG002
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Secondary
Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Temporary interruption of study treatment may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG001
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG002
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Secondary
Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 2
Dose reduction for individual participant allowed if a DLT occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG001
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG002
Rhabdomyosarcoma: Part 2
Primary
Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 1
TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG003
Temsirolimus 150 mg/m^2: Part 1
Primary
Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 1
TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period. National Cancer Institute (NCI)-graded Common Toxicity Criteria (CTC) provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Primary
Number of Participants Who Died: Part 1
Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Primary
Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 1
SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability / incapacity or are a congenital anomaly or birth defect in the offspring of a study subject. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Primary
Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 1
Temporary interruption of study treatment; may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Primary
Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 1
Dose reduction for individual participant allowed if a dose limiting toxicity (DLT) occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Primary
Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 1
Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees Celsius (C), respiratory rate >20 beats per minute (bpm), and systolic and diastolic blood pressure (BP) >200/110 millimeters of mercury (mmHg). Participants may be reported in more than 1 category.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG003
Secondary
Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 2
Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees C, respiratory rate >20 bpm, and systolic and diastolic BP >200/110 mmHg. Participants may be reported in more than 1 category.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG001
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG002
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Secondary
Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 2
Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG001
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG002
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Secondary
Maximum Observed Plasma Concentration (Cmax): Part 2
Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Part 2
Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion..
Units
Counts
Participants
OG000
Secondary
Average Plasma Concentration (Cavg): Part 2
Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Part 2
Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG000
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 2
Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Median
Full Range
hr
0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Part 2
Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG000
Secondary
Plasma Decay Half-Life (t1/2): Part 2
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for.
Posted
Mean
Standard Deviation
hr
0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Part 2
Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG000
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 2
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
hr*ng/mL
0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Part 2
Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG000
Primary
Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 1
Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.
Safety population included all participants who received at least 1 dose of study medication.
Posted
Number
participants
Baseline up to EOT (within 30 days of last dose)
ID
Title
Description
OG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
OG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Primary
Percentage of Participants With Objective Response (OR) at Week 12: Part 2
Measured as Complete response (CR), Very good partial response (VGPR), or Partial response (PR) on at least 2 occasions greater than or equal to (>=) 4 weeks apart within first 12 weeks. CR=disappearance of all primary and metastatic lesions; Homovanillic acid, Vanillymandelic acid (HVA/VMA) normal; bone marrow immunocytology negative. VGPR=disappearance of all metastatic lesions (residual areas of uptake on bone permitted); 90 to 99 percent (%) decrease in primary disease measurement; HVA/VMA normal or both decreased >90%. PR=at least 50% decrease in primary and metastatic disease. Number of bone sites decreased by at least 50%.
Efficacy evaluable population included all participants who received at least 3 doses of study treatment. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
OG001
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Secondary
Area Under the Concentration-time Curve at Steady State (AUCss): Part 2
AUCss is a measure of the serum concentration of the drug at steady state. It is used to characterize drug absorption.
Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
hr*ng/mL
0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Part 2
Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG000
Secondary
Clearance (CL): Part 2
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
L/hr
0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Part 2
Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG000
Secondary
Concentration in Plasma (Cp) and Concentration in Plasma at Time Zero (Cp Time 0): Part 1 and Part 2
Pharmacokinetic parameters determined in whole blood; derived from the concentration-versus-time profiles using noncompartmental analysis method. Measured as nanograms per milliliter (ng/mL).
Data was not analyzed.
Posted
Part 1: 0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2; Part2: 0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)
ID
Title
Description
OG000
Part 1
Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
OG001
Part 2
Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
Secondary
Number of Participants for Change From Baseline in the Phosphorylation of Mammalian Target of Rapamycin (mTOR) Pathway Proteins: Part 1 and Part 2
Optional bone marrow sampling for pharmacodynamic analysis of effects of study treatment. Data may not be collected for a majority of patients and was not to be summarized if collection was sparse.
Data was not analyzed.
Posted
Part 1:Baseline,1,2,6,24,168 hrs post-dose of Cycle 1;additional 0 (Pre-dose),24,72,96 hrs, Day 16 to 21 of cycle 2, EOT(within 30 days of last dose); Part 2:Baseline,Day16 to 21 in Cycle 2, at time of disease progression, EOT(within 30 days of last dose)
ID
Title
Description
OG000
Part 1
Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
OG001
Part 2
Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
Time Frame
Not provided
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Temsirolimus 10 mg/m^2: Part 1
Temsirolimus 10 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
2
4
4
4
EG001
Temsirolimus 25 mg/m^2: Part 1
Temsirolimus 25 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
2
5
5
5
EG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
2
3
3
3
EG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
3
7
7
7
EG004
High-grade Glioma: Part 2
Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10
17
17
17
EG005
Neuroblastoma: Part 2
Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
6
19
19
19
EG006
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
6
16
15
16
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pain
General disorders
COSTART
Systematic Assessment
Organ System "General disorders" equivalent to COSTART "Body as a whole".
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG0031 affected7 at risk
EG004
Fever
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Sarcoma
General disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Chest pain
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Headache
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Infection
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Sepsis
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypotension
Cardiac disorders
COSTART
Systematic Assessment
Organ System "Cardiac disorders" equivalent to COSTART "Cardiovascular system".
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Shock
Cardiac disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
COSTART
Systematic Assessment
Organ System "Gastrointestinal disorders" equivalent to COSTART "Digestive system".
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Convulsion
Nervous system disorders
COSTART
Systematic Assessment
Organ System "Nervous system disorders" equivalent to COSTART "Nervous system".
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Grand mal convulsion
Nervous system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Paresis
Nervous system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
Organ System "Respiratory, thoracic, and mediastinal disorders" equivalent to COSTART "Respiratory system".
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Abscess
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Nail infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Brain herniation
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Rhabdomyosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Drooling
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Grand mal convulsion
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pain
General disorders
COSTART
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected5 at risk
EG0023 affected3 at risk
EG0032 affected7 at risk
EG0040 affected17 at risk
EG0050 affected19 at risk
EG0060 affected16 at risk
Fever
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected5 at risk
EG0021 affected3 at risk
EG003
Infection
General disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0022 affected3 at risk
EG003
Asthenia
General disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Headache
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected5 at risk
EG0021 affected3 at risk
EG003
Abdominal pain
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0021 affected3 at risk
EG003
Allergic reaction
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Back pain
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Face edema
General disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Accidental injury
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Cellulitis
General disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Injection site reaction
General disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Hypotension
Cardiac disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Syncope
Cardiac disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0003 affected4 at risk
EG0012 affected5 at risk
EG0021 affected3 at risk
EG003
Anorexia
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0002 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Mucositis
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0002 affected4 at risk
EG0011 affected5 at risk
EG0021 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0022 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0022 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Esophagitis
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0021 affected3 at risk
EG003
Oral moniliasis
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0022 affected3 at risk
EG003
Cheilitis
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Gamma glutamyl transpeptidase increased
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Rectal disorder
Gastrointestinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Glycosuria
Endocrine disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Anemia
Blood and lymphatic system disorders
COSTART
Systematic Assessment
EG0003 affected4 at risk
EG0010 affected5 at risk
EG0022 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
COSTART
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected5 at risk
EG0023 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0023 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected5 at risk
EG0023 affected3 at risk
EG003
International normalised ratio increased
Blood and lymphatic system disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Activated partial thromboplastin time prolonged
Blood and lymphatic system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Ecchymosis
Blood and lymphatic system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Fibrinogen increased
Blood and lymphatic system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hemolysis
Blood and lymphatic system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Hypoproteinemia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0002 affected4 at risk
EG0011 affected5 at risk
EG0022 affected3 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected5 at risk
EG0021 affected3 at risk
EG003
Hyperlipemia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0013 affected5 at risk
EG0022 affected3 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0002 affected4 at risk
EG0011 affected5 at risk
EG0022 affected3 at risk
EG003
SGOT increased
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected5 at risk
EG0022 affected3 at risk
EG003
Hypercholesteremia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected5 at risk
EG0021 affected3 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0022 affected3 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
SGPT increased
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0022 affected3 at risk
EG003
Alkaline phosphatase increased
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Bilirubinemia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Hypermagnesemia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Weight loss
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Creatinine increased
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypernatremia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Peripheral edema
Metabolism and nutrition disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
COSTART
Systematic Assessment
Organ System "Musculoskeletal and connective tissue disorders" equivalent to COSTART "Musculoskeletal system".
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Neuropathy
Nervous system disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected5 at risk
EG0021 affected3 at risk
EG003
Depression
Nervous system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Hostility
Nervous system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Convulsion
Nervous system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypesthesia
Nervous system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Insomnia
Nervous system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Paresthesia
Nervous system disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cough increased
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0002 affected4 at risk
EG0011 affected5 at risk
EG0021 affected3 at risk
EG003
Rhinitis
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Upper respiratory infection
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hemoptysis
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Laryngitis
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Lung hemorrhage
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pharyngitis
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Sinusitis
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0021 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Herpes simplex
Skin and subcutaneous tissue disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0021 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0022 affected3 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Application site reaction
Skin and subcutaneous tissue disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Exfoliative dermatitis
Skin and subcutaneous tissue disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
COSTART
Systematic Assessment
Organ System "Ear and labyrinth disorders" equivalent to COSTART "Special senses".
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Conjunctival injection
Eye disorders
COSTART
Systematic Assessment
Organ System "Eye disorders" equivalent to COSTART "Special senses".
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Eye pain
Eye disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Lacrimation disorder
Eye disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Abnormal vision
Eye disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Urinary frequency
Renal and urinary disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected5 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
COSTART
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hematuria
Renal and urinary disorders
COSTART
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Local reaction to procedure
Investigations
COSTART
Systematic Assessment
Organ System "Investigations" equivalent to COSTART "Adverse event associated with miscellaneous factors".
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cyanosis
Cardiac disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Tympanic membrane perforation
Ear and labyrinth disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Exophthalmos
Eye disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Eye pain
Eye disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Breath odour
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Gingivitis
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Oesophageal pain
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Rectal discharge
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Axillary pain
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Catheter site rash
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Device occlusion
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Injection site haematoma
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Irritability
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Ulcer
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Abscess
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Acne pustular
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Ear infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Localised infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Nail infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Otitis externa
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Paronychia
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pyoderma
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Radiation injury
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood albumin decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood calcium decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood fibrinogen increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood glucose decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood glucose increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood magnesium increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood potassium decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood potassium increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood pressure decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood sodium decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Blood urea increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cardiac murmur
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
High density lipoprotein decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Respiratory rate
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Weight increased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Neuroblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Accessory nerve disorder
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Attention deficit/hyperactivity disorder
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Urethral pain
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Urogenital haemorrhage
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Suffocation feeling
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Nail bed inflammation
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Nail bed tenderness
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Rash follicular
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Nail operation
Surgical and medical procedures
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Haematoma
Vascular disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA (14.1)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D000230
Adenocarcinoma
D009369
Neoplasms
Ancestor Terms
ID
Term
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C401859
temsirolimus
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0051 subjects
FG0060 subjects
16 subjects
FG00518 subjects
FG00616 subjects
0 subjects
FG0048 subjects
FG00514 subjects
FG00613 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0061 subjects
Symptomatic deterioration
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0061 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Title
Measurements
BG0002
BG0013
BG0025
>=18 to less than or equal to 21 years
Title
Measurements
BG0005
BG0017
BG00212
25
Male
BG00011
BG00135
BG00246
7
7
SAEs
Title
Measurements
OG0002
OG0012
OG0022
OG0033
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Title
Measurements
OG0000(9.40 to 10.11)
OG0010(23.20 to 25.40)
OG0020(71.77 to 75.26)
OG0032(89.21 to 156.50)
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Cycle 1 (n = 4, 5, 3, 7)
Title
Measurements
OG000307± 91.3
OG001487± 141
OG002480± 135
OG0039230± 18200
Cycle 2 (n = 4, 4, 3, 5)
Title
Measurements
OG000252± 98.3
OG001403± 128
OG002807± 279
OG003
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Cycle 1 (n = 4, 5, 3, 7)
Title
Measurements
OG0001± 0.143
OG0011.1± 0.074
OG0021.3± 0.231
OG0031.1± 0.218
Cycle 2 (n = 4, 4, 3, 5)
Title
Measurements
OG0001.1± 0.236
OG0011.7± 0.983
OG0021.2± 0.202
OG003
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG0035
Title
Denominators
Categories
Cycle 1 (n = 4, 4, 1, 4)
Title
Measurements
OG00010.6± 0.556
OG00116.4± 6.9
OG00224± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG00319.3± 10.5
Cycle 2 (n = 4, 3, 3, 5)
Title
Measurements
OG00014.4± 4.42
OG00114.3± 10.4
OG00225.4± 1.83
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Cycle 1 (n = 4, 5, 3, 7)
Title
Measurements
OG0001670± 730
OG0013890± 3190
OG0023750± 2420
OG0039680± 12800
Cycle 2 (n = 4, 4, 3, 5)
Title
Measurements
OG0001520± 583
OG0011930± 1090
OG0023420± 1230
OG003
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG0035
Title
Denominators
Categories
Cycle 1 (n = 4, 4, 1, 4)
Title
Measurements
OG0002000± 959
OG0014640± 3430
OG0022810± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG00313000± 17000
Cycle 2 (n = 4, 3, 3, 5)
Title
Measurements
OG0001600± 540
OG0012580± 768
OG0023500± 1140
OG003
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG0035
Title
Denominators
Categories
Cycle 1 (n = 4, 4, 1, 4)
Title
Measurements
OG0007.02± 3.68
OG00110.4± 6.45
OG00238.1± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG00347.9± 45.8
Cycle 2 (n = 4, 3, 3, 5)
Title
Measurements
OG0008.99± 5.27
OG00113.8± 9.06
OG00230.6± 15.5
OG003
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG0035
Title
Denominators
Categories
Cycle 1 (n = 4, 4, 1, 4)
Title
Measurements
OG00085.2± 35
OG001189± 44.2
OG002783± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG003512± 689
Cycle 2 (n = 4, 3, 3, 5)
Title
Measurements
OG000250± 290
OG001201± 132
OG002601± 347
OG003
OG002
Temsirolimus 75 mg/m^2: Part 1
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG0037
Title
Denominators
Categories
Complete response
Title
Measurements
OG0001
OG0010
OG0020
OG0030
Partial response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Stable disease
Title
Measurements
OG0000
OG0012
OG0023
OG003
Progressive disease
Title
Measurements
OG0003
OG0012
OG0020
OG003
Unknown response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG00015
OG00115
OG00212
Title
Denominators
Categories
Title
Measurements
OG00046.67(21.27 to 73.41)
OG00140.00(16.34 to 67.71)
OG0028.33(0.21 to 38.48)
Units
Counts
Participants
OG00017
OG00119
OG00216
Title
Denominators
Categories
AEs
Title
Measurements
OG00017
OG00119
OG00216
SAEs
Title
Measurements
OG00010
OG0016
OG0026
Units
Counts
Participants
OG00017
OG00119
OG00216
Title
Denominators
Categories
Title
Measurements
OG00017
OG00118
OG00213
Units
Counts
Participants
OG00017
OG00119
OG00216
Title
Denominators
Categories
Title
Measurements
OG0005
OG00111
OG0026
Counts
Participants
OG00017
OG00119
OG00216
Title
Denominators
Categories
Died=Yes
Title
Measurements
OG0005
OG0012
OG0024
Died within 30 days of last dose
Title
Measurements
OG0003
OG0010
OG0023
Units
Counts
Participants
OG00017
OG00119
OG00216
Title
Denominators
Categories
Title
Measurements
OG0002
OG0013
OG0023
Units
Counts
Participants
OG00017
OG00119
OG00216
Title
Denominators
Categories
Title
Measurements
OG0009
OG00112
OG0026
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG00017
OG00119
OG00216
Title
Denominators
Categories
Title
Measurements
OG0005
OG00110
OG0026
Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Title
Measurements
OG0004
OG0015
OG0023
OG0037
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0022
OG0034
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Died=Yes
Title
Measurements
OG0003
OG0011
OG0020
OG0030
Died within 30 days of last dose
Title
Measurements
OG0002
OG0010
OG0020
OG003
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0021
OG0032
Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Temperature >39 degrees C
Title
Measurements
OG0001
OG0012
OG0021
OG0033
Respiratory rate >20 bpm
Title
Measurements
OG0004
OG0015
OG0023
OG003
Systolic/Diastolic BP >200/110 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG003
Units
Counts
Participants
OG00017
OG00119
OG00216
Title
Denominators
Categories
Temperature >39 degrees C
Title
Measurements
OG0000
OG0010
OG0020
Respiratory rate >20 bpm
Title
Measurements
OG00016
OG00118
OG00214
Systolic/Diastolic BP >200/110 mmHg
Title
Measurements
OG0001
OG0010
OG0020
Units
Counts
Participants
OG00017
OG00119
OG00216
Title
Denominators
Categories
Title
Measurements
OG00017
OG00119
OG00215
35
Title
Denominators
Categories
Title
Measurements
OG0006280± 21000
31
Title
Denominators
Categories
Title
Measurements
OG00082.8± 143
35
Title
Denominators
Categories
Title
Measurements
OG0001.00(0.00 to 6.00)
26
Title
Denominators
Categories
Title
Measurements
OG00030.65± 13.63
35
Title
Denominators
Categories
Title
Measurements
OG00013100± 22700
OG003
Temsirolimus 150 mg/m^2: Part 1
Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0037
Title
Denominators
Categories
Title
Measurements
OG0004
OG0015
OG0023
OG0037
OG002
Rhabdomyosarcoma: Part 2
Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.