NCT01736917 · ADVERSE EVENTS

Adverse events

Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors · Source last updated 2016-05-25

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: Duration of participation on study, up to 8 days.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied. \- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days). Acute emesis prophylaxis: * Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards. * Dexamethasone 20mg PO (orally) daily, D1 and 2 * Fosaprepitant 150mg IV on day 3 Delayed emesis prophylaxis: * Fosaprepitant 150mg IV on D5 * Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator * No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl	9 / 65	65 / 65	Not reported / Not reported

Group identifiers: EG000: Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone

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
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
DIARRHEA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
ENTEROCOLITIS INFECTIOUS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
2
num At Risk
65
num Events
2
term
FEBRILE NEUTROPENIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
HYPERKALEMIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
HYPERTENSION
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
MYOCARDIAL INFARCTION
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
PAIN IN EXTREMITY
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
SEPSIS

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
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
6
num At Risk
65
num Events
7
term
ABDOMINAL PAIN
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
3
num At Risk
65
num Events
4
term
ALANINE AMINOTRANSFERASE INCREASED
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
2
num At Risk
65
num Events
2
term
ALKALINE PHOSPHATASE INCREASED
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
ALLERGIC REACTION
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
14
num At Risk
65
num Events
14
term
ALOPECIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
13
num At Risk
65
num Events
21
term
ANEMIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
19
num At Risk
65
num Events
26
term
ANOREXIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
9
num At Risk
65
num Events
11
term
ANXIETY
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
AORTIC VALVE DISEASE
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
ARTHRALGIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
2
term
ASPARTATE AMINOTRANSFERASE INCREASED
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
AZOOSPERMIA

Complete source fields

event Groups

description
Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied. \- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days). Acute emesis prophylaxis: * Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards. * Dexamethasone 20mg PO (orally) daily, D1 and 2 * Fosaprepitant 150mg IV on day 3 Delayed emesis prophylaxis: * Fosaprepitant 150mg IV on D5 * Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator * No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl
id
EG000
other Num Affected
65
other Num At Risk
65
serious Num Affected
9
serious Num At Risk
65
title
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
6
num At Risk
65
num Events
7
term
ABDOMINAL PAIN
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
3
num At Risk
65
num Events
4
term
ALANINE AMINOTRANSFERASE INCREASED
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
2
num At Risk
65
num Events
2
term
ALKALINE PHOSPHATASE INCREASED
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
ALLERGIC REACTION
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
14
num At Risk
65
num Events
14
term
ALOPECIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
13
num At Risk
65
num Events
21
term
ANEMIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
19
num At Risk
65
num Events
26
term
ANOREXIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
9
num At Risk
65
num Events
11
term
ANXIETY
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
AORTIC VALVE DISEASE
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
ARTHRALGIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
2
term
ASPARTATE AMINOTRANSFERASE INCREASED
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
AZOOSPERMIA

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
DIARRHEA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
ENTEROCOLITIS INFECTIOUS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
2
num At Risk
65
num Events
2
term
FEBRILE NEUTROPENIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
HYPERKALEMIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
HYPERTENSION
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
MYOCARDIAL INFARCTION
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
PAIN IN EXTREMITY
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv4
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
SEPSIS

time Frame

Duration of participation on study, up to 8 days.

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

Preserved source evidence · Not medical advice