Trial Outcomes & Findings for Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors (NCT NCT01736917)
NCT ID: NCT01736917
Last Updated: 2016-05-25
Results Overview
complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Days 1-8 of chemotherapy regimen
Results posted on
2016-05-25
Participant Flow
Participant milestones
| Measure |
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/m\^2 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
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
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/m\^2 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
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Protocol Violation
|
10
|
Baseline Characteristics
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors
Baseline characteristics by cohort
| Measure |
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
n=64 Participants
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/m\^2 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
|
|---|---|
|
Age, Continuous
|
33 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG PS 0
|
59 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG PS 1
|
4 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG PS 2
|
1 participants
n=99 Participants
|
|
Cancer Stage
Cancer Stage I
|
27 participants
n=99 Participants
|
|
Cancer Stage
Cancer Stage II
|
24 participants
n=99 Participants
|
|
Cancer Stage
Cancer Stage III
|
11 participants
n=99 Participants
|
|
Cancer Stage
Cancer Stage IS
|
1 participants
n=99 Participants
|
|
Cancer Stage
Cancer Stage Unknown
|
1 participants
n=99 Participants
|
|
Prior Chemotherapy
Participants with Prior Chemotherapy
|
5 participants
n=99 Participants
|
|
Prior Chemotherapy
Participants without Prior Chemotherapy
|
59 participants
n=99 Participants
|
|
Chemotherapy Regimen
Bleomycin, etoposide, cisplatin
|
51 participants
n=99 Participants
|
|
Chemotherapy Regimen
Etoposide, cisplatin
|
10 participants
n=99 Participants
|
|
Chemotherapy Regimen
Vinblastine, ifosfamide, cisplatin
|
2 participants
n=99 Participants
|
|
Chemotherapy Regimen
Cisplatin, Epirubicin
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Days 1-8 of chemotherapy regimencomplete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications
Outcome measures
| Measure |
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
n=54 Participants
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
|
|---|---|
|
Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting
acute phase(days 1 through 5)
|
29.6 percentage of participants
|
|
Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting
delayed phase (days 6 through 8)
|
46.3 percentage of participants
|
|
Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting
overall
|
24.1 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1-8 of chemotherapy regimentotal number of emetic episodes
Outcome measures
| Measure |
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
n=54 Participants
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
|
|---|---|
|
Total Number of Emetic Episodes
|
29 episodes
|
SECONDARY outcome
Timeframe: Days 1-8 of chemotherapy regimenTotal number of patients who received rescue medications.
Outcome measures
| Measure |
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
n=54 Participants
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
|
|---|---|
|
Use of Rescue Medications.
|
37 participants
|
SECONDARY outcome
Timeframe: Days 1-8 of chemotherapy regimenPopulation: 54 patients completed the VAS on all 8 days and were eligible for analysis.
the patient's self-reported assessment of nausea Days 1-8 using a 0-100mm visual analog scale (VAS) median. The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. Median VAS scores (in mm) are reported, per day.
Outcome measures
| Measure |
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
n=54 Participants
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
|
|---|---|
|
Self-Reported Assessment of Nausea
median VAS score - day 6
|
12.5 millimeters
Interval 0.0 to 80.0
|
|
Self-Reported Assessment of Nausea
median VAS score - day 5
|
23.5 millimeters
Interval 0.0 to 92.0
|
|
Self-Reported Assessment of Nausea
median VAS score - day 7
|
7 millimeters
Interval 0.0 to 90.0
|
|
Self-Reported Assessment of Nausea
median VAS score - day 8
|
3 millimeters
Interval 0.0 to 84.0
|
|
Self-Reported Assessment of Nausea
median VAS score - day 1
|
0 millimeters
Interval 0.0 to 24.0
|
|
Self-Reported Assessment of Nausea
median VAS score - day 2
|
0 millimeters
Interval 0.0 to 76.0
|
|
Self-Reported Assessment of Nausea
median VAS score - day 3
|
4.5 millimeters
Interval 0.0 to 60.0
|
|
Self-Reported Assessment of Nausea
median VAS score - day 4
|
18.5 millimeters
Interval 0.0 to 95.0
|
Adverse Events
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Serious events: 9 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
n=65 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
DIARRHEA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Vascular disorders
HYPERTENSION
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Infections and infestations
SEPSIS
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
Other adverse events
| Measure |
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
n=65 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
9.2%
6/65 • Number of events 7 • Duration of participation on study, up to 8 days.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
4.6%
3/65 • Number of events 4 • Duration of participation on study, up to 8 days.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Immune system disorders
ALLERGIC REACTION
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
21.5%
14/65 • Number of events 14 • Duration of participation on study, up to 8 days.
|
|
Blood and lymphatic system disorders
ANEMIA
|
20.0%
13/65 • Number of events 21 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
29.2%
19/65 • Number of events 26 • Duration of participation on study, up to 8 days.
|
|
Psychiatric disorders
ANXIETY
|
13.8%
9/65 • Number of events 11 • Duration of participation on study, up to 8 days.
|
|
Cardiac disorders
AORTIC VALVE DISEASE
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
1.5%
1/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Reproductive system and breast disorders
AZOOSPERMIA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.2%
6/65 • Number of events 6 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
BLOATING
|
6.2%
4/65 • Number of events 4 • Duration of participation on study, up to 8 days.
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
General disorders
CHILLS
|
4.6%
3/65 • Number of events 4 • Duration of participation on study, up to 8 days.
|
|
Investigations
CHOLESTEROL HIGH
|
4.6%
3/65 • Number of events 3 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
CONSTIPATION
|
26.2%
17/65 • Number of events 19 • Duration of participation on study, up to 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.9%
11/65 • Number of events 11 • Duration of participation on study, up to 8 days.
|
|
Investigations
CREATININE INCREASED
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Psychiatric disorders
DEPRESSION
|
4.6%
3/65 • Number of events 3 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
DIARRHEA
|
12.3%
8/65 • Number of events 10 • Duration of participation on study, up to 8 days.
|
|
Nervous system disorders
DIZZINESS
|
7.7%
5/65 • Number of events 6 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
DRY MOUTH
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Nervous system disorders
DYSGEUSIA
|
4.6%
3/65 • Number of events 3 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
36.9%
24/65 • Number of events 29 • Duration of participation on study, up to 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
13.8%
9/65 • Number of events 9 • Duration of participation on study, up to 8 days.
|
|
General disorders
EDEMA LIMBS
|
6.2%
4/65 • Number of events 5 • Duration of participation on study, up to 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
General disorders
FATIGUE
|
81.5%
53/65 • Number of events 78 • Duration of participation on study, up to 8 days.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
General disorders
FEVER
|
10.8%
7/65 • Number of events 7 • Duration of participation on study, up to 8 days.
|
|
Vascular disorders
FLUSHING
|
7.7%
5/65 • Number of events 5 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
GASTRITIS
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
16.9%
11/65 • Number of events 11 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Nervous system disorders
HEADACHE
|
15.4%
10/65 • Number of events 15 • Duration of participation on study, up to 8 days.
|
|
Renal and urinary disorders
HEMATURIA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
21.5%
14/65 • Number of events 15 • Duration of participation on study, up to 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Vascular disorders
HOT FLASHES
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
7.7%
5/65 • Number of events 10 • Duration of participation on study, up to 8 days.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Vascular disorders
HYPERTENSION
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
4.6%
3/65 • Number of events 3 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
6.2%
4/65 • Number of events 9 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
1.5%
1/65 • Number of events 7 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
7.7%
5/65 • Number of events 10 • Duration of participation on study, up to 8 days.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Vascular disorders
HYPOTENSION
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
4.6%
3/65 • Number of events 4 • Duration of participation on study, up to 8 days.
|
|
Investigations
INR INCREASED
|
1.5%
1/65 • Number of events 5 • Duration of participation on study, up to 8 days.
|
|
Psychiatric disorders
INSOMNIA
|
20.0%
13/65 • Number of events 13 • Duration of participation on study, up to 8 days.
|
|
General disorders
LOCALIZED EDEMA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
7.7%
5/65 • Number of events 9 • Duration of participation on study, up to 8 days.
|
|
General disorders
MALAISE
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
15.4%
10/65 • Number of events 11 • Duration of participation on study, up to 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
NAUSEA
|
81.5%
53/65 • Number of events 90 • Duration of participation on study, up to 8 days.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
4.6%
3/65 • Number of events 3 • Duration of participation on study, up to 8 days.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
21.5%
14/65 • Number of events 27 • Duration of participation on study, up to 8 days.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
ORAL PAIN
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
General disorders
PAIN
|
21.5%
14/65 • Number of events 14 • Duration of participation on study, up to 8 days.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.2%
4/65 • Number of events 4 • Duration of participation on study, up to 8 days.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Nervous system disorders
PARESTHESIA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
6.2%
4/65 • Number of events 4 • Duration of participation on study, up to 8 days.
|
|
Investigations
PLATELET COUNT DECREASED
|
12.3%
8/65 • Number of events 14 • Duration of participation on study, up to 8 days.
|
|
Nervous system disorders
PRESYNCOPE
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
7.7%
5/65 • Number of events 5 • Duration of participation on study, up to 8 days.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
9.2%
6/65 • Number of events 6 • Duration of participation on study, up to 8 days.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Nervous system disorders
SINUS PAIN
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Infections and infestations
SINUSITIS
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
3.1%
2/65 • Number of events 3 • Duration of participation on study, up to 8 days.
|
|
Nervous system disorders
SOMNOLENCE
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
6.2%
4/65 • Number of events 5 • Duration of participation on study, up to 8 days.
|
|
Nervous system disorders
SYNCOPE
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Ear and labyrinth disorders
TINNITUS
|
12.3%
8/65 • Number of events 9 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
TOOTHACHE
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
1.5%
1/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
3.1%
2/65 • Number of events 2 • Duration of participation on study, up to 8 days.
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.5%
1/65 • Number of events 1 • Duration of participation on study, up to 8 days.
|
|
Gastrointestinal disorders
VOMITING
|
13.8%
9/65 • Number of events 9 • Duration of participation on study, up to 8 days.
|
|
Investigations
WEIGHT GAIN
|
12.3%
8/65 • Number of events 8 • Duration of participation on study, up to 8 days.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
20.0%
13/65 • Number of events 26 • Duration of participation on study, up to 8 days.
|
Additional Information
Clinical Data Coordinator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place