NCT00587964 · ADVERSE EVENTS

Adverse events

Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases · Source last updated 2016-02-22

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment - Stereotactic Radiosurgery Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.	16 / 51	0 / 51	Not reported / Not reported

Group identifiers: EG000: Treatment - Stereotactic Radiosurgery

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Ischemia cerebrovascular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
3
num At Risk
51
num Events
3
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
2
num At Risk
51
num Events
2
term
General symptom
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Radiation oesophagitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
2
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Hypomagnesemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
2
num At Risk
51
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
2
num At Risk
51
num Events
2
term
Neurological disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Peripheral motor neuropathy

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

event Groups

description
Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
id
EG000
other Num Affected
0
other Num At Risk
51
serious Num Affected
16
serious Num At Risk
51
title
Treatment - Stereotactic Radiosurgery

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Ischemia cerebrovascular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
3
num At Risk
51
num Events
3
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
2
num At Risk
51
num Events
2
term
General symptom
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Radiation oesophagitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
2
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Hypomagnesemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
2
num At Risk
51
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
2
num At Risk
51
num Events
2
term
Neurological disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-2.0
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
term
Peripheral motor neuropathy

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Preserved source evidence · Not medical advice