Trial Outcomes & Findings for A Study of Pemetrexed in Children With Recurrent Cancer (NCT NCT00520936)
NCT ID: NCT00520936
Last Updated: 2011-02-25
Results Overview
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent \[%\])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)\*100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
baseline to measured progressive disease (up to 1 year)
Results posted on
2011-02-25
Participant Flow
Participant milestones
| Measure |
Osteosarcoma
Pemetrexed 1910 milligrams per meters squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old)
|
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Rhabdomyosarcoma
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Neuroblastoma (Measureable Disease)
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Ependymoma
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Non-Brainstem High-Grade Glioma
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
9
|
5
|
6
|
10
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
7
|
7
|
5
|
5
|
10
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
2
|
0
|
1
|
0
|
4
|
1
|
Reasons for withdrawal
| Measure |
Osteosarcoma
Pemetrexed 1910 milligrams per meters squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old)
|
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Rhabdomyosarcoma
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Neuroblastoma (Measureable Disease)
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Ependymoma
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Non-Brainstem High-Grade Glioma
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Toxicity Requiring Removal from Study
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Pemetrexed in Children With Recurrent Cancer
Baseline characteristics by cohort
| Measure |
Osteosarcoma
n=10 Participants
Pemetrexed 1910 milligrams per meters squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old)
|
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
n=11 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Rhabdomyosarcoma
n=9 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Neuroblastoma (Measureable Disease)
n=5 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)
n=6 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Ependymoma
n=10 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor
n=11 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Non-Brainstem High-Grade Glioma
n=10 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
14.94 years
STANDARD_DEVIATION 4.28 • n=99 Participants
|
18.24 years
STANDARD_DEVIATION 3.35 • n=107 Participants
|
8.74 years
STANDARD_DEVIATION 4.96 • n=206 Participants
|
6.23 years
STANDARD_DEVIATION 2.98 • n=7 Participants
|
9.62 years
STANDARD_DEVIATION 5.38 • n=31 Participants
|
8.42 years
STANDARD_DEVIATION 4.59 • n=30 Participants
|
12.00 years
STANDARD_DEVIATION 7.13 • n=3 Participants
|
12.75 years
STANDARD_DEVIATION 5.15 • n=6 Participants
|
11.96 years
STANDARD_DEVIATION 5.97 • n=114 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
32 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
40 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
14 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
48 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
8 participants
n=206 Participants
|
5 participants
n=7 Participants
|
5 participants
n=31 Participants
|
9 participants
n=30 Participants
|
10 participants
n=3 Participants
|
10 participants
n=6 Participants
|
61 participants
n=114 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
1 participants
n=30 Participants
|
1 participants
n=3 Participants
|
0 participants
n=6 Participants
|
11 participants
n=114 Participants
|
|
Karnofsky Performance Score
100
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
|
Karnofsky Performance Score
90
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
|
Karnofsky Performance Score
80
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Karnofsky Performance Score
70
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Karnofsky Performance Score
50
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Karnofsky Performance Score
Missing
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
54 Participants
n=114 Participants
|
|
Lansky Play Score
100
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
18 Participants
n=114 Participants
|
|
Lansky Play Score
90
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
18 Participants
n=114 Participants
|
|
Lansky Play Score
80
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
11 Participants
n=114 Participants
|
|
Lansky Play Score
70
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Lansky Play Score
60
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
|
Lansky Play Score
50
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
|
Lansky Play Score
Missing
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
18 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: baseline to measured progressive disease (up to 1 year)Population: All treated participants.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent \[%\])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)\*100.
Outcome measures
| Measure |
Osteosarcoma
n=10 Participants
Pemetrexed 1910 milligrams per meters squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old)
|
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
n=11 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Rhabdomyosarcoma
n=9 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Neuroblastoma (Measureable Disease)
n=5 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)
n=6 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Ependymoma
n=10 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor
n=11 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Non-Brainstem High-Grade Glioma
n=10 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Overall Tumor Response (Response Rate)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: every cycle (up to 2 years and 7 months)Population: All treated participants.
AdEERS= Adverse Event Expedited Reporting System; AE = adverse event. Patients may be counted in more than 1 category. Includes events that were considered possibly related to study drug (PRSD) as judged by the investigator.
Outcome measures
| Measure |
Osteosarcoma
n=10 Participants
Pemetrexed 1910 milligrams per meters squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old)
|
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
n=11 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Rhabdomyosarcoma
n=9 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Neuroblastoma (Measureable Disease)
n=5 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)
n=6 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Ependymoma
n=10 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor
n=11 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
Non-Brainstem High-Grade Glioma
n=10 Participants
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
>=1 AdEERs possibly related to study drug
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
Discontinued due to AE possibly related to drug
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
Died on therapy possibly related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
Died within 31 days of last dose of drug PRSD
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here.
The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. Results of this optional research may be reported in the future by the Children's Oncology Group in the peer-reviewed literature.
Outcome measures
Outcome data not reported
Adverse Events
Pemetrexed
Serious events: 21 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed
n=72 participants at risk
Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient \<12 months old)
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.6%
4/72 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.4%
1/72 • Number of events 1
|
|
Blood and lymphatic system disorders
Infection
|
2.8%
2/72 • Number of events 2
|
|
Blood and lymphatic system disorders
Infection with normal ANC or Grade 1
|
5.6%
4/72 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukocytes
|
4.2%
3/72 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.2%
3/72 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
4.2%
3/72 • Number of events 3
|
|
Blood and lymphatic system disorders
Platelets
|
2.8%
2/72 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
2.8%
2/72 • Number of events 2
|
|
Gastrointestinal disorders
Pain: Tumor pain
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Ulceration
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/72 • Number of events 2
|
|
General disorders
Fever
|
1.4%
1/72 • Number of events 1
|
|
General disorders
Flushing
|
1.4%
1/72 • Number of events 1
|
|
General disorders
Pain: Extremity-limb
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Dyspnea
|
2.8%
2/72 • Number of events 2
|
|
Infections and infestations
Rash/desquamation
|
1.4%
1/72 • Number of events 1
|
|
Investigations
GGT
|
1.4%
1/72 • Number of events 1
|
|
Metabolism and nutrition disorders
Albumin, serum-low
|
1.4%
1/72 • Number of events 1
|
|
Metabolism and nutrition disorders
Calcium, serum-low
|
1.4%
1/72 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/72 • Number of events 1
|
|
Metabolism and nutrition disorders
Phosphate, serum-low
|
4.2%
3/72 • Number of events 3
|
|
Metabolism and nutrition disorders
Potassium, serum-low
|
2.8%
2/72 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hemorrhage, CNS
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Hydrocephalus
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Hypotension
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Mood alteration: Depression
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.4%
1/72 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Death not associated with CTCAE term
|
4.2%
3/72 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
1.4%
1/72 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed
n=72 participants at risk
Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient \<12 months old)
|
|---|---|
|
Blood and lymphatic system disorders
Infection with normal ANC or Grade 1
|
2.8%
2/72 • Number of events 2
|
|
Cardiac disorders
Dermatology/Skin - Other
|
1.4%
1/72 • Number of events 1
|
|
Cardiac disorders
Pulmonary/Upper Respiratory - Other
|
1.4%
1/72 • Number of events 1
|
|
Cardiac disorders
Thrombosis/thrombus/embolism
|
1.4%
1/72 • Number of events 1
|
|
Congenital, familial and genetic disorders
Sodium, serum-low
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage, GI: Rectum
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Pain: Tumor pain
|
1.4%
1/72 • Number of events 1
|
|
General disorders
Fever
|
2.8%
2/72 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seizure
|
2.8%
2/72 • Number of events 2
|
|
Renal and urinary disorders
Hemorrhage, GU: Urinary NOS
|
1.4%
1/72 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/72 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
2/72 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60