NCT03155620 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- The reporting timeframe includes adverse events occurring within 14 days following a biopsy performed after enrollment on this study. All-Cause Mortality monitored/assessed up to 5 years.
- Other-event reporting threshold
- 0%
Biopsy related AE reporting is collected routinely using case report forms. The SAE table reflects biopsy related CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining biopsy related CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients enrolled after Stage 1 (12/31/21) are excluded from AE reporting. All-Cause Mortality includes all deaths collected on the study for enrolled patients.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol | 2 / 1343 | 1 / 1343 | 906 / 1377 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1343
- term
- Infections and infestations - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1343
- term
- Meningitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1343
- term
- Laryngeal edema
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1343
- term
- Headache
Complete source fields
- description
- Biopsy related AE reporting is collected routinely using case report forms. The SAE table reflects biopsy related CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining biopsy related CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients enrolled after Stage 1 (12/31/21) are excluded from AE reporting. All-Cause Mortality includes all deaths collected on the study for enrolled patients.
- event Groups
- deaths Num Affected
- 906
- deaths Num At Risk
- 1377
- description
- Patients undergo biopsy along with tumor mutational screening of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Patients also undergo collection of blood samples for research purposes.
- id
- EG000
- other Num Affected
- 1
- other Num At Risk
- 1343
- serious Num Affected
- 2
- serious Num At Risk
- 1343
- title
- NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1343
- term
- Headache
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1343
- term
- Infections and infestations - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1343
- term
- Meningitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1343
- term
- Laryngeal edema
- time Frame
- The reporting timeframe includes adverse events occurring within 14 days following a biopsy performed after enrollment on this study. All-Cause Mortality monitored/assessed up to 5 years.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle