NCT00516503 · ADVERSE EVENTS

Adverse events

Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer · Source last updated 2017-08-24

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
Baclofen-amitriptyline Hydrochloride-ketamine Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.	1 / 101	48 / 101	Not reported / Not reported
Placebo Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically	1 / 102	45 / 102	Not reported / Not reported

Group identifiers: EG000: Baclofen-amitriptyline Hydrochloride-ketamine · 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
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
0
num At Risk
102
num Events
0
term
Thrombosis

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
Ear and labyrinth disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
2
num At Risk
102
num Events
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
24
num At Risk
101
num Events
62
group Id
EG001
num Affected
28
num At Risk
102
num Events
71
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
18
num At Risk
101
num Events
55
group Id
EG001
num Affected
23
num At Risk
102
num Events
55
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Ileal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
0
num At Risk
102
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
2
num At Risk
102
num Events
4
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
0
num At Risk
102
num Events
0
term
Stomach pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
0
num At Risk
102
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Fatigue

Complete source fields

event Groups

description
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
id
EG000
other Num Affected
48
other Num At Risk
101
serious Num Affected
1
serious Num At Risk
101
title
Baclofen-amitriptyline Hydrochloride-ketamine
description
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
id
EG001
other Num Affected
45
other Num At Risk
102
serious Num Affected
1
serious Num At Risk
102
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
2
num At Risk
102
num Events
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
24
num At Risk
101
num Events
62
group Id
EG001
num Affected
28
num At Risk
102
num Events
71
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
18
num At Risk
101
num Events
55
group Id
EG001
num Affected
23
num At Risk
102
num Events
55
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Ileal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
0
num At Risk
102
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
2
num At Risk
102
num Events
4
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
0
num At Risk
102
num Events
0
term
Stomach pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
0
num At Risk
102
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
101
num Events
0
group Id
EG001
num Affected
1
num At Risk
102
num Events
1
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
101
num Events
1
group Id
EG001
num Affected
0
num At Risk
102
num Events
0
term
Thrombosis

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Preserved source evidence · Not medical advice