Trial Outcomes & Findings for Aprepitant + a 5HT3 + Dexamethasone in Patients With Germ Cell Tumors (NCT NCT00572572)
NCT ID: NCT00572572
Last Updated: 2016-04-06
Results Overview
Participants were followed for chemotherapy induced nausea and vomiting (CINV) through day 8 of cycle 2. Complete response is defined as no emetic episodes and no use of rescue medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
69 participants
Primary outcome timeframe
Participants were evaluated from start of treatment through day 8 of cycle 2.
Results posted on
2016-04-06
Participant Flow
Participant milestones
| Measure |
Arm A: Aprepitant, Then Placebo
Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2
Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.
|
Arm B: Placebo, Then Aprepitant
Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2
Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
|
Overall Study
COMPLETED
|
32
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Arm A: Aprepitant, Then Placebo
Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2
Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.
|
Arm B: Placebo, Then Aprepitant
Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2
Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
Baseline Characteristics
Aprepitant + a 5HT3 + Dexamethasone in Patients With Germ Cell Tumors
Baseline characteristics by cohort
| Measure |
Arm A: Aprepitant, Then Placebo
n=35 Participants
Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2
Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.
|
Arm B: Placebo, Then Aprepitant
n=34 Participants
Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2
Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
30 years
STANDARD_DEVIATION 8.6 • n=107 Participants
|
31 years
STANDARD_DEVIATION 10.16 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
34 participants
n=107 Participants
|
69 participants
n=206 Participants
|
|
Prior Therapies
No Prior Therapy
|
29 participants
n=99 Participants
|
28 participants
n=107 Participants
|
57 participants
n=206 Participants
|
|
Prior Therapies
Chemotherapy Multiple Agent Systemic (CMAS)
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Prior Therapies
CMAS and Surgery
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Participants were evaluated from start of treatment through day 8 of cycle 2.Participants were followed for chemotherapy induced nausea and vomiting (CINV) through day 8 of cycle 2. Complete response is defined as no emetic episodes and no use of rescue medication.
Outcome measures
| Measure |
Aprepitant
n=60 Participants
Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
|
Placebo
n=60 Participants
Placebo cycle whether placebo then aprepitant or aprepitant then placebo
|
|---|---|---|
|
Complete Response.
|
47 percentage of evaluable subjects
|
15 percentage of evaluable subjects
|
SECONDARY outcome
Timeframe: Participants were evaluated from cycle days 1-5.Proportion of patients with no emesis regardless of use of rescue medication during cycle days 1-5.
Outcome measures
| Measure |
Aprepitant
n=60 Participants
Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
|
Placebo
n=60 Participants
Placebo cycle whether placebo then aprepitant or aprepitant then placebo
|
|---|---|---|
|
Proportion of Patients With no Emesis During the Acute CINV Time Period (Cycle Days 1-5)
|
80 percentage of evaluable subjects
|
52 percentage of evaluable subjects
|
SECONDARY outcome
Timeframe: Participants were evaluated from cycle days 6-8.Proportion of patients with no emesis regardless of use of rescue medication during cycle days 6-8.
Outcome measures
| Measure |
Aprepitant
n=60 Participants
Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
|
Placebo
n=60 Participants
Placebo cycle whether placebo then aprepitant or aprepitant then placebo
|
|---|---|---|
|
Proportion of Patients With no Emesis During the Delayed CINV Time Period (Cycle Days 6-8)
|
92 percentage of evaluable subjects
|
78 percentage of evaluable subjects
|
SECONDARY outcome
Timeframe: Days 1-8Population: There were 54 subjects during the Aprepitant treatment and 61 subjects during the Placebo treatment for days 1-8 that had complete data for the analysis of the visual analouge scale for nausea and vomiting.
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. The mean VAS scores for days 1-8 combined, by treatment (Aprepitant vs. Placebo) were reported.
Outcome measures
| Measure |
Aprepitant
n=54 Participants
Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
|
Placebo
n=61 Participants
Placebo cycle whether placebo then aprepitant or aprepitant then placebo
|
|---|---|---|
|
Visual Analouge (VAS) 100mm Scale Score
|
22.6 mm
Standard Deviation 18.7
|
27.1 mm
Standard Deviation 22.1
|
SECONDARY outcome
Timeframe: Days 1-8Population: There were 64 subjects during the Aprepitant treatment and 62 subjects during the Placebo treatment for days 1-8 that had complete data for the analysis of the M.D. Anderson Symptom Inventory. The mean MDASI scores for days 1-8 combined, by treatment (Aprepitant vs. Placebo) were reported.
The MD Anderson Symptom Inventory (MDASI) is a brief measure of the severity and impact of cancer-related symptoms. Thirteen core items measure the severity of symptoms and six additional items measure the impact of symptoms. All items are rated on a scale from 0 (not present or did not interfere) to 10 (maximal severity or interference). The mean value of the total nineteen items ranges from 0 to 10.
Outcome measures
| Measure |
Aprepitant
n=64 Participants
Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
|
Placebo
n=62 Participants
Placebo cycle whether placebo then aprepitant or aprepitant then placebo
|
|---|---|---|
|
MD Anderson Symptom Inventory Score
|
3.2 units on a scale
Standard Deviation 3.4
|
2.9 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: There were 49 subjects during the Aprepitant treatment and the Placebo treatment for each cycle that had complete data for the analysis of the preferred treatment cycle.
Participants were asked which treatment cycles was preferable - aprepitant or placebo cycle.
Outcome measures
| Measure |
Aprepitant
n=49 Participants
Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
|
Placebo
n=49 Participants
Placebo cycle whether placebo then aprepitant or aprepitant then placebo
|
|---|---|---|
|
Preferred Treatment Cycle
|
78 percentage of subjects with a preference
|
22 percentage of subjects with a preference
|
Adverse Events
Aprepitant, Then Placebo
Serious events: 7 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo, Then Aprepitant.
Serious events: 9 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aprepitant, Then Placebo
n=35 participants at risk
Arm A, Study Cycle 1
Arm B, Study Cycle 2
Aprepitant: Aprepitant 125mg PO day 3 then 80mg on days 4 through 7
Subjects will be stratified prior to randomization based on previous administration of chemotherapy.
Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.
Arm A, Study Cycle 1
Arm B, Study Cycle 2
|
Placebo, Then Aprepitant.
n=34 participants at risk
Arm A, Study Cycle 2
Arm B, Study Cycle 1
Placebo: Matched placebo PO daily on days 3 through 7
Subjects will be stratified prior to randomization based on previous administration of chemotherapy.
Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.
Arm A, Study Cycle 2
Arm B, Study Cycle 1
|
|---|---|---|
|
Cardiac disorders
CARDIAC ISCHEMIA/INFARCTION
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
COLITIS, INFECTIOUS (E.G., CLOSTRIDIUM DIFFICILE)
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
DEHYDRATION
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
FEBRILE NEUTROPENIA(ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Infections and infestations
INFECTION (ANC <1.0 X 10E9/L) / VEIN
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
0.00%
0/35
|
5.9%
2/34 • Number of events 3
|
|
Vascular disorders
THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
Other adverse events
| Measure |
Aprepitant, Then Placebo
n=35 participants at risk
Arm A, Study Cycle 1
Arm B, Study Cycle 2
Aprepitant: Aprepitant 125mg PO day 3 then 80mg on days 4 through 7
Subjects will be stratified prior to randomization based on previous administration of chemotherapy.
Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.
Arm A, Study Cycle 1
Arm B, Study Cycle 2
|
Placebo, Then Aprepitant.
n=34 participants at risk
Arm A, Study Cycle 2
Arm B, Study Cycle 1
Placebo: Matched placebo PO daily on days 3 through 7
Subjects will be stratified prior to randomization based on previous administration of chemotherapy.
Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.
Arm A, Study Cycle 2
Arm B, Study Cycle 1
|
|---|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
2.9%
1/35 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
|
Investigations
ALKALINE PHOSPHATASE
|
8.6%
3/35 • Number of events 3
|
5.9%
2/34 • Number of events 2
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY - OTHER (SPECIFY, __)
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
14.3%
5/35 • Number of events 6
|
8.8%
3/34 • Number of events 4
|
|
Gastrointestinal disorders
ANOREXIA
|
25.7%
9/35 • Number of events 12
|
23.5%
8/34 • Number of events 8
|
|
Psychiatric disorders
APNEA
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
5.7%
2/35 • Number of events 3
|
5.9%
2/34 • Number of events 2
|
|
Investigations
BILIRUBIN (HYPERBILIRUBINEMIA)
|
2.9%
1/35 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER (SPECIFY, __)
|
0.00%
0/35
|
2.9%
1/34 • Number of events 4
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
8.6%
3/35 • Number of events 3
|
2.9%
1/34 • Number of events 2
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER (SPECIFY, __)
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
CONSTIPATION
|
17.1%
6/35 • Number of events 6
|
38.2%
13/34 • Number of events 14
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.3%
5/35 • Number of events 5
|
20.6%
7/34 • Number of events 7
|
|
Investigations
CREATININE
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
DEHYDRATION
|
5.7%
2/35 • Number of events 2
|
11.8%
4/34 • Number of events 4
|
|
Gastrointestinal disorders
DENTAL: TEETH
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHEA
|
11.4%
4/35 • Number of events 4
|
14.7%
5/34 • Number of events 6
|
|
Nervous system disorders
DIZZINESS
|
2.9%
1/35 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
20.0%
7/35 • Number of events 7
|
17.6%
6/34 • Number of events 6
|
|
Blood and lymphatic system disorders
EDEMA: HEAD AND NECK
|
2.9%
1/35 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
8.6%
3/35 • Number of events 4
|
5.9%
2/34 • Number of events 2
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
54.3%
19/35 • Number of events 25
|
61.8%
21/34 • Number of events 28
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
11.4%
4/35 • Number of events 4
|
20.6%
7/34 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER (SPECIFY, __)
|
5.7%
2/35 • Number of events 3
|
8.8%
3/34 • Number of events 3
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
8.6%
3/35 • Number of events 4
|
2.9%
1/34 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
34.3%
12/35 • Number of events 15
|
44.1%
15/34 • Number of events 17
|
|
Ear and labyrinth disorders
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
37.1%
13/35 • Number of events 16
|
35.3%
12/34 • Number of events 14
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
37.1%
13/35 • Number of events 18
|
20.6%
7/34 • Number of events 9
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / RECTUM
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
|
0.00%
0/35
|
2.9%
1/34 • Number of events 2
|
|
Cardiac disorders
HYPERTENSION
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
|
Gastrointestinal disorders
ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION)
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
INFECTION (ANC <1.0 X 10E9/L) / JOINT
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
INFECTION (ANC <1.0 X 10E9/L) / PELVIS NOS
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LARYNX
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LYMPHATIC
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
|
2.9%
1/35 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SOFT TISSUE NOS
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / WOUND
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
General disorders
INSOMNIA
|
31.4%
11/35 • Number of events 11
|
35.3%
12/34 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
JOINT-FUNCTION
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
22.9%
8/35 • Number of events 8
|
20.6%
7/34 • Number of events 18
|
|
Investigations
LIPASE
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
|
Psychiatric disorders
MOOD ALTERATION / AGITATION
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
25.7%
9/35 • Number of events 10
|
20.6%
7/34 • Number of events 7
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
8.6%
3/35 • Number of events 3
|
8.8%
3/34 • Number of events 3
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
8.6%
3/35 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / STOMACH
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CAVITY/PARANASAL SINUS REACTIONS
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
60.0%
21/35 • Number of events 32
|
67.6%
23/34 • Number of events 29
|
|
Nervous system disorders
NEUROLOGY - OTHER (SPECIFY, __)
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
11.4%
4/35 • Number of events 4
|
20.6%
7/34 • Number of events 7
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
34.3%
12/35 • Number of events 20
|
23.5%
8/34 • Number of events 17
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
8.6%
3/35 • Number of events 3
|
5.9%
2/34 • Number of events 2
|
|
General disorders
PAIN / BACK
|
11.4%
4/35 • Number of events 4
|
17.6%
6/34 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
8.6%
3/35 • Number of events 4
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / DENTAL/TEETH/PERIDONTAL
|
0.00%
0/35
|
5.9%
2/34 • Number of events 2
|
|
Gastrointestinal disorders
PAIN / ESOPHAGUS
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
General disorders
PAIN / HEAD/HEADACHE
|
8.6%
3/35 • Number of events 3
|
8.8%
3/34 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
8.6%
3/35 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
|
General disorders
PAIN / NECK
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
PAIN / NEURALGIA/PERIPHERAL NERVE
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
General disorders
PAIN / PAIN NOS
|
2.9%
1/35 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Reproductive system and breast disorders
PAIN / PROSTATE
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / RECTUM
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Reproductive system and breast disorders
PAIN / SCROTUM
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Reproductive system and breast disorders
PAIN / TESTICLE
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / THROAT/PHARYNX/LARYNX
|
0.00%
0/35
|
8.8%
3/34 • Number of events 3
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
5.7%
2/35 • Number of events 2
|
11.8%
4/34 • Number of events 4
|
|
Vascular disorders
PHLEBITIS (INCLUDING SUPERFICIAL THROMBOSIS)
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Blood and lymphatic system disorders
PLATELETS
|
14.3%
5/35 • Number of events 5
|
23.5%
8/34 • Number of events 15
|
|
Investigations
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
5.7%
2/35 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
2.9%
1/35 • Number of events 1
|
5.9%
2/34 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
2.9%
1/35 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
5.7%
2/35 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER (SPECIFY, __)
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
General disorders
RIGORS/CHILLS
|
5.7%
2/35 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
2.9%
1/35 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
|
Psychiatric disorders
SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS BRADYCARDIA
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
General disorders
SWEATING (DIAPHORESIS)
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
14.3%
5/35 • Number of events 7
|
5.9%
2/34 • Number of events 2
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Ear and labyrinth disorders
TINNITUS
|
17.1%
6/35 • Number of events 6
|
8.8%
3/34 • Number of events 3
|
|
Nervous system disorders
TREMOR
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Investigations
TRIGLYCERIDE, SERUM-HIGH (HYPERTRIGLYCERIDEMIA)
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
22.9%
8/35 • Number of events 9
|
41.2%
14/34 • Number of events 19
|
|
General disorders
WEIGHT GAIN
|
8.6%
3/35 • Number of events 3
|
8.8%
3/34 • Number of events 3
|
|
General disorders
WEIGHT LOSS
|
5.7%
2/35 • Number of events 2
|
0.00%
0/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place