NCT02489422 · ADVERSE EVENTS

Adverse events

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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: Over 8 weeks
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group I (Yoga Skills Training) Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies	4 / 23	1 / 23	2 / 23
Group II (Attention Control) Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies	3 / 21	2 / 21	2 / 21

Group identifiers: EG000: Group I (Yoga Skills Training) · EG001: Group II (Attention Control)

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
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
23
num Events
2
group Id
EG001
num Affected
2
num At Risk
21
num Events
2
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Bowel perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Bile duct stenosis

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
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Toothache

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
23
description
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies
id
EG000
other Num Affected
1
other Num At Risk
23
serious Num Affected
4
serious Num At Risk
23
title
Group I (Yoga Skills Training)
deaths Num Affected
2
deaths Num At Risk
21
description
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
id
EG001
other Num Affected
2
other Num At Risk
21
serious Num Affected
3
serious Num At Risk
21
title
Group II (Attention Control)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Toothache

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
23
num Events
2
group Id
EG001
num Affected
2
num At Risk
21
num Events
2
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Bowel perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Bile duct stenosis

time Frame

Over 8 weeks

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Preserved source evidence · Not medical advice