NCT00719563 · ADVERSE EVENTS

Adverse events

American Ginseng in Treating Patients With Fatigue Caused by Cancer · Source last updated 2017-02-09

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: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ginseng Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	1 / 168	115 / 168	Not reported / Not reported
Placebo Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	5 / 169	112 / 169	Not reported / Not reported

Group identifiers: EG000: Ginseng · EG001: Placebo

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
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
2
num At Risk
169
num Events
3
term
Insomnia

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
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
2
num At Risk
168
num Events
3
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
4
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Dry eye syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Colonic obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
2
num At Risk
168
num Events
2
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
2
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
2
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Mucositis oral

Complete source fields

event Groups

description
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
id
EG000
other Num Affected
115
other Num At Risk
168
serious Num Affected
1
serious Num At Risk
168
title
Ginseng
description
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
id
EG001
other Num Affected
112
other Num At Risk
169
serious Num Affected
5
serious Num At Risk
169
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
2
num At Risk
168
num Events
3
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
4
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Dry eye syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Colonic obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
2
num At Risk
168
num Events
2
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
2
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
2
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Mucositis oral

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
1
num At Risk
168
num Events
1
group Id
EG001
num Affected
0
num At Risk
169
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
1
num At Risk
169
num Events
1
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAEV3.0
stats
group Id
EG000
num Affected
0
num At Risk
168
num Events
0
group Id
EG001
num Affected
2
num At Risk
169
num Events
3
term
Insomnia

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Preserved source evidence · Not medical advice