NCT00895245 · ADVERSE EVENTS

Adverse events

Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy · Source last updated 2017-05-18

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: up to 7 weeks
Other-event reporting threshold: 0%

Only grade 2 and higher adverse events were recorded.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion. fosaprepitant dimeglumine: Given IV cisplatin: Given IV palonosetron hydrochloride: Given IV dexamethasone: Given IV and orally Functional Living Index-Emesis Questionnaire: Ancillary studies Emesis Diary: Ancillary studies Radiotherapy: Undergo r	0 / 6	6 / 6	Not reported / Not reported

Group identifiers: EG000: Arm I

Serious adverse events

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

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
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
5
num At Risk
6
num Events
5
term
nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
4
num At Risk
6
num Events
4
term
leukocytes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Ataxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
3
num At Risk
6
num Events
3
term
Vomiting

Complete source fields

description

Only grade 2 and higher adverse events were recorded.

event Groups

description
Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion. fosaprepitant dimeglumine: Given IV cisplatin: Given IV palonosetron hydrochloride: Given IV dexamethasone: Given IV and orally Functional Living Index-Emesis Questionnaire: Ancillary studies Emesis Diary: Ancillary studies Radiotherapy: Undergo r
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
0
serious Num At Risk
6
title
Arm I

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
5
num At Risk
6
num Events
5
term
nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
4
num At Risk
6
num Events
4
term
leukocytes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Ataxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
3
num At Risk
6
num Events
3
term
Vomiting

time Frame

up to 7 weeks

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

Preserved source evidence · Not medical advice