TriangleNCT00520936 · OUTCOME
Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- every cycle (up to 2 years and 7 months)
What was measured
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.
Analysis population: All treated participants.
Groups in this outcome
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)
| Group | Source count |
|---|---|
| Osteosarcoma | 10 |
| Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors | 11 |
| Rhabdomyosarcoma | 9 |
| Neuroblastoma (Measureable Disease) | 5 |
| Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) | 6 |
| Ependymoma | 10 |
| Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor | 11 |
| Non-Brainstem High-Grade Glioma | 10 |
Reported measurements
>=1 AdEERs possibly related to study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osteosarcoma | 3 | Not reported | Not reported | Not reported | Not reported |
| Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors | 2 | Not reported | Not reported | Not reported | Not reported |
| Rhabdomyosarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Neuroblastoma (Measureable Disease) | 2 | Not reported | Not reported | Not reported | Not reported |
| Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) | 3 | Not reported | Not reported | Not reported | Not reported |
| Ependymoma | 2 | Not reported | Not reported | Not reported | Not reported |
| Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor | 2 | Not reported | Not reported | Not reported | Not reported |
| Non-Brainstem High-Grade Glioma | 2 | Not reported | Not reported | Not reported | Not reported |
Discontinued due to AE possibly related to drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osteosarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors | 1 | Not reported | Not reported | Not reported | Not reported |
| Rhabdomyosarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Neuroblastoma (Measureable Disease) | 0 | Not reported | Not reported | Not reported | Not reported |
| Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) | 0 | Not reported | Not reported | Not reported | Not reported |
| Ependymoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor | 2 | Not reported | Not reported | Not reported | Not reported |
| Non-Brainstem High-Grade Glioma | 0 | Not reported | Not reported | Not reported | Not reported |
Died on therapy possibly related to study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osteosarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors | 0 | Not reported | Not reported | Not reported | Not reported |
| Rhabdomyosarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Neuroblastoma (Measureable Disease) | 0 | Not reported | Not reported | Not reported | Not reported |
| Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) | 0 | Not reported | Not reported | Not reported | Not reported |
| Ependymoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Brainstem High-Grade Glioma | 0 | Not reported | Not reported | Not reported | Not reported |
Died within 31 days of last dose of drug PRSD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osteosarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors | 0 | Not reported | Not reported | Not reported | Not reported |
| Rhabdomyosarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Neuroblastoma (Measureable Disease) | 0 | Not reported | Not reported | Not reported | Not reported |
| Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) | 0 | Not reported | Not reported | Not reported | Not reported |
| Ependymoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Brainstem High-Grade Glioma | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- title
- >=1 AdEERs possibly related to study drug
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 0
- title
- Discontinued due to AE possibly related to drug
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Died on therapy possibly related to study drug
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Died within 31 days of last dose of drug PRSD
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 10
- units
- Participants
- description
- 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.
- groups
- description
- Pemetrexed 1910 milligrams per meters squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old)
- id
- OG000
- title
- Osteosarcoma
- description
- Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
- id
- OG001
- title
- Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
- description
- Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
- id
- OG002
- title
- Rhabdomyosarcoma
- description
- Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
- id
- OG003
- title
- Neuroblastoma (Measureable Disease)
- description
- Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
- id
- OG004
- title
- Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)
- description
- Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
- id
- OG005
- title
- Ependymoma
- description
- Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
- id
- OG006
- title
- Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor
- description
- Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
- id
- OG007
- title
- Non-Brainstem High-Grade Glioma
- param Type
- NUMBER
- population Description
- All treated participants.
- reporting Status
- POSTED
- time Frame
- every cycle (up to 2 years and 7 months)
- title
- Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice