NCT00589121 · ADVERSE EVENTS

Adverse events

Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg · Source last updated 2019-06-12

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%

Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A - Chemotherapy Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost	2 / 10	8 / 10	Not reported / Not reported
Cohort B - No Chemotherapy Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost	13 / 79	73 / 79	Not reported / Not reported

Group identifiers: EG000: Cohort A - Chemotherapy · EG001: Cohort B - No Chemotherapy

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
79
term
Blood disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
2
num At Risk
79
term
Edema limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Infection [other]
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
79
term
Opportunistic infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
3
num At Risk
79
term
Skin infection [with normal or Grade 1-2 ANC]
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
79
term
Wound infection [with normal or Grade 1-2 ANC]
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Arterial injury - Extremity-lower
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
79
term
Dermatitis radiation

Other reported adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
79
term
Blood disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
10
group Id
EG001
num Affected
19
num At Risk
79
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Hemolysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Arrhythmia supraventricular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Left ventricular failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Premature ventricular contractions
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Supraventricular tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Diplopia

Complete source fields

description

event Groups

description
Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
id
EG000
other Num Affected
8
other Num At Risk
10
serious Num Affected
2
serious Num At Risk
10
title
Cohort A - Chemotherapy
description
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
id
EG001
other Num Affected
73
other Num At Risk
79
serious Num Affected
13
serious Num At Risk
79
title
Cohort B - No Chemotherapy

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
79
term
Blood disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
10
group Id
EG001
num Affected
19
num At Risk
79
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Hemolysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Arrhythmia supraventricular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Left ventricular failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Premature ventricular contractions
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Supraventricular tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Diplopia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
79
term
Blood disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
2
num At Risk
79
term
Edema limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Infection [other]
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
79
term
Opportunistic infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
3
num At Risk
79
term
Skin infection [with normal or Grade 1-2 ANC]
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
79
term
Wound infection [with normal or Grade 1-2 ANC]
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
79
term
Arterial injury - Extremity-lower
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
79
term
Dermatitis radiation

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Preserved source evidence · Not medical advice