NCT02717455 · ADVERSE EVENTS

Adverse events

Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma · Source last updated 2024-04-25

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: Approximately 2 years after initiation of protocol treatment
Other-event reporting threshold: 5%

Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included a) grade 1 or 2 AEs if attribution was at least possibly related to panobinostat, and b) all grade 3+ AEs on treatment and within 30 days off treatment. All these AEs were summarized in SAE and Other AE tables below. All mortalities on this study were due to disease, except one for upper airway obstruction. Two patients on stratum 2 did not start protocol therapy and were not counted as at risk.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Stratum 1, Dose Level 1 (10 mg/m^2) Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 10 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	9 / 13	13 / 13	13 / 13
Stratum 1, Dose Level 2 (16 mg/m^2) Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	4 / 6	6 / 6	5 / 6
Stratum 2, Dose Level 1 (16 mg/m^2) Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	0 / 3	3 / 3	3 / 3
Stratum 2, Dose Level 2 (22 mg/m^2) Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 22 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	5 / 11	11 / 11	5 / 11
Stratum 2, Dose Level 3 (28 mg/m^2) Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 28 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	4 / 12	12 / 12	11 / 12
Stratum 2, Dose Level 4 (36 mg/m^2) Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 36 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	4 / 6	6 / 6	5 / 6

Group identifiers: EG000: Stratum 1, Dose Level 1 (10 mg/m^2) · EG001: Stratum 1, Dose Level 2 (16 mg/m^2) · EG002: Stratum 2, Dose Level 1 (16 mg/m^2) · EG003: Stratum 2, Dose Level 2 (22 mg/m^2) · EG004: Stratum 2, Dose Level 3 (28 mg/m^2) · EG005: Stratum 2, Dose Level 4 (36 mg/m^2)

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
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
3
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
2
num At Risk
12
num Events
4
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
term
Hypokalemia

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
stats
group Id
EG000
num Affected
3
num At Risk
13
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
3
num At Risk
11
num Events
6
group Id
EG004
num Affected
7
num At Risk
12
num Events
16
group Id
EG005
num Affected
3
num At Risk
6
num Events
7
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Cardiac disorders - other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Right ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
2
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Extraocular muscle paresis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
3
group Id
EG003
num Affected
2
num At Risk
11
num Events
3
group Id
EG004
num Affected
1
num At Risk
12
num Events
4
group Id
EG005
num Affected
1
num At Risk
6
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
2
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
3
num At Risk
6
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
group Id
EG001
num Affected
3
num At Risk
6
num Events
3
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
8
num At Risk
11
num Events
13
group Id
EG004
num Affected
9
num At Risk
12
num Events
15
group Id
EG005
num Affected
4
num At Risk
6
num Events
6
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Gastroesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
3
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Gastrointestinal disorders - other, specify

Complete source fields

description

event Groups

deaths Num Affected
13
deaths Num At Risk
13
description
Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 10 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
13
other Num At Risk
13
serious Num Affected
9
serious Num At Risk
13
title
Stratum 1, Dose Level 1 (10 mg/m^2)
deaths Num Affected
5
deaths Num At Risk
6
description
Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Stratum 1, Dose Level 2 (16 mg/m^2)
deaths Num Affected
3
deaths Num At Risk
3
description
Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Stratum 2, Dose Level 1 (16 mg/m^2)
deaths Num Affected
5
deaths Num At Risk
11
description
Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 22 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
id
EG003
other Num Affected
11
other Num At Risk
11
serious Num Affected
5
serious Num At Risk
11
title
Stratum 2, Dose Level 2 (22 mg/m^2)
deaths Num Affected
11
deaths Num At Risk
12
description
Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 28 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
id
EG004
other Num Affected
12
other Num At Risk
12
serious Num Affected
4
serious Num At Risk
12
title
Stratum 2, Dose Level 3 (28 mg/m^2)
deaths Num Affected
5
deaths Num At Risk
6
description
Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 36 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
id
EG005
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Stratum 2, Dose Level 4 (36 mg/m^2)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
13
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
3
num At Risk
11
num Events
6
group Id
EG004
num Affected
7
num At Risk
12
num Events
16
group Id
EG005
num Affected
3
num At Risk
6
num Events
7
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Cardiac disorders - other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Right ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
2
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Extraocular muscle paresis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
3
group Id
EG003
num Affected
2
num At Risk
11
num Events
3
group Id
EG004
num Affected
1
num At Risk
12
num Events
4
group Id
EG005
num Affected
1
num At Risk
6
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
2
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
3
num At Risk
6
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
group Id
EG001
num Affected
3
num At Risk
6
num Events
3
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
8
num At Risk
11
num Events
13
group Id
EG004
num Affected
9
num At Risk
12
num Events
15
group Id
EG005
num Affected
4
num At Risk
6
num Events
6
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Gastroesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
3
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Gastrointestinal disorders - other, specify

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
3
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
2
num At Risk
12
num Events
4
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
term
Hypokalemia

time Frame

Approximately 2 years after initiation of protocol treatment

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice