Trial Outcomes & Findings for PS-341 Alone and PS-341 Plus EPOCH Chemotherapy to Treat Non-Hodgkin's Lymphoma (NCT NCT00054665)
NCT ID: NCT00054665
Last Updated: 2012-09-11
Results Overview
Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
18 weeks
Results posted on
2012-09-11
Participant Flow
1 patient was deemed ineligible and did not receive any treatment. In addition, per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators (e.g. participants can skip A)
Participant milestones
| Measure |
Part A: PS-341 Alone
1.3 mg/m\^2 intravenous bolus injection over 3-5 seconds every 3 weeks.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
|
Part B: PS-341 & EPOCH
PS-341 1.3 mg/m\^2 intravenous bolus injection over 3-5 seconds every 3 weeks. EPOCH (etoposide 50 mg/m\^2 day continuous intravenous infusion days 1-4, doxorubicin 10 mg/m\^2 day continuous intravenous infusion days 1-4, vincristine 0.4 mg/m\^2/day continuous intravenous infusion days 1-4, cyclophosphamide 750 mg/m\^2 intravenous bolus day 5, prednisone 60 mg/m\^2 by mouth days 1-5, and filgrastim 300 micrograms subcutaneously day 6 to absolute neutrophil count (ANC) recovery \>/= 5000/mm\^3.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
|
|---|---|---|
|
Part A
STARTED
|
23
|
0
|
|
Part A
COMPLETED
|
23
|
0
|
|
Part A
NOT COMPLETED
|
0
|
0
|
|
Part B
STARTED
|
0
|
44
|
|
Part B
COMPLETED
|
0
|
44
|
|
Part B
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PS-341 Alone and PS-341 Plus EPOCH Chemotherapy to Treat Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A & B: PS-341 and PS-341 & EPOCH
n=50 Participants
Part A: PS-341 Alone
1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks Part B: PS-341 \& EPOCH
PS-341: level 1: 0.5 mg/m\^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m\^2 IV days 1, 4; level 3: 1.5 mg/m\^2 IV days 1, 4; level 4: 1.7 mg/m\^2 IV days 1, 4.
EPOCH: Etoposide: 50 mg/m\^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m\^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m\^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m\^2 day IV day 5 bolus; Prednisone: 60 mg/m\^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm\^3. Repeat cycles every 21 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age Continuous
|
53.04 years
STANDARD_DEVIATION 16.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 weeksClinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease
Outcome measures
| Measure |
Part A: PS-341 Alone
n=23 Participants
1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
|
Part B: PS-341 & EPOCH
n=44 Participants
PS-341: level 1: 0.5 mg/m\^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m\^2 IV days 1, 4; level 3: 1.5 mg/m\^2 IV days 1, 4; level 4: 1.7 mg/m\^2 IV days 1, 4.
EPOCH: Etoposide: 50 mg/m\^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m\^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m\^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m\^2 day IV day 5 bolus; Prednisone: 60 mg/m\^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm\^3. Repeat cycle every 21 days.
|
|---|---|---|
|
Clinical Response Rate
Partial response
|
1 Participants
|
7 Participants
|
|
Clinical Response Rate
Complete response
|
0 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 43 monthsHere is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Part A: PS-341 Alone
n=23 Participants
1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
|
Part B: PS-341 & EPOCH
n=44 Participants
PS-341: level 1: 0.5 mg/m\^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m\^2 IV days 1, 4; level 3: 1.5 mg/m\^2 IV days 1, 4; level 4: 1.7 mg/m\^2 IV days 1, 4.
EPOCH: Etoposide: 50 mg/m\^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m\^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m\^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m\^2 day IV day 5 bolus; Prednisone: 60 mg/m\^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm\^3. Repeat cycle every 21 days.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
23 Participants
|
44 Participants
|
Adverse Events
Part A: PS-341 Alone
Serious events: 21 serious events
Other events: 24 other events
Deaths: 0 deaths
Part B: PS-341 & EPOCH
Serious events: 40 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: PS-341 Alone
n=24 participants at risk
PS-341 1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
|
Part B: PS-341 & EPOCH
n=44 participants at risk
PS-341: level 1: 0.5 mg/m\^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m\^2 IV days 1, 4; level 3: 1.5 mg/m\^2 IV days 1, 4; level 4: 1.7 mg/m\^2 IV days 1, 4.
EPOCH: Etoposide: 50 mg/m\^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m\^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m\^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m\^2 day IV day 5 bolus; Prednisone: 60 mg/m\^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm\^3. Repeat cycles every 21 days.
|
|---|---|---|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
33.3%
8/24 • Number of events 9
|
22.7%
10/44 • Number of events 14
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<
|
12.5%
3/24 • Number of events 3
|
6.8%
3/44 • Number of events 3
|
|
General disorders
Rigors, chills
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
General disorders
Sweating (diaphoresis)
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
4.2%
1/24 • Number of events 2
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
12.5%
3/24 • Number of events 3
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
4.2%
1/24 • Number of events 2
|
0.00%
0/44
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
4/24 • Number of events 4
|
18.2%
8/44 • Number of events 8
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • Number of events 3
|
13.6%
6/44 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
29.2%
7/24 • Number of events 9
|
25.0%
11/44 • Number of events 16
|
|
Gastrointestinal disorders
Nausea
|
29.2%
7/24 • Number of events 8
|
27.3%
12/44 • Number of events 17
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
8.3%
2/24 • Number of events 2
|
18.2%
8/44 • Number of events 14
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
12.5%
3/24 • Number of events 3
|
13.6%
6/44 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Number of events 1
|
11.4%
5/44 • Number of events 7
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
4.2%
1/24 • Number of events 1
|
6.8%
3/44 • Number of events 5
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
4.2%
1/24 • Number of events 1
|
20.5%
9/44 • Number of events 11
|
|
Hepatobiliary disorders
SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
8.3%
2/24 • Number of events 4
|
9.1%
4/44 • Number of events 5
|
|
Hepatobiliary disorders
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
12.5%
3/24 • Number of events 3
|
6.8%
3/44 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.2%
1/24 • Number of events 1
|
9.1%
4/44 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.2%
1/24 • Number of events 2
|
0.00%
0/44
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.2%
1/24 • Number of events 2
|
11.4%
5/44 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.3%
2/24 • Number of events 3
|
9.1%
4/44 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.2%
1/24 • Number of events 2
|
9.1%
4/44 • Number of events 5
|
|
Nervous system disorders
Ataxia (incoordination)
|
4.2%
1/24 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Dizziness/lightheadedness
|
8.3%
2/24 • Number of events 3
|
9.1%
4/44 • Number of events 7
|
|
Nervous system disorders
Neuropathy - motor
|
4.2%
1/24 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
|
Nervous system disorders
Neuropathy-sensory
|
20.8%
5/24 • Number of events 5
|
18.2%
8/44 • Number of events 10
|
|
Nervous system disorders
Syncope (fainting)
|
4.2%
1/24 • Number of events 2
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Ocular/Visual-Other (Specify, periorbital edema)
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
12.5%
3/24 • Number of events 3
|
11.4%
5/44 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
4.2%
1/24 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
12.5%
3/24 • Number of events 4
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Neuropathic pain
|
4.2%
1/24 • Number of events 4
|
2.3%
1/44 • Number of events 1
|
|
Ear and labyrinth disorders
Inner ear/hearing
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Prolonged QTc interval (QTc > 0.48 seconds)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Weight loss
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Ileus (or neuroconstipation)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/24
|
2.3%
1/44 • Number of events 2
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
Hepatobiliary disorders
Bilirubin
|
0.00%
0/24
|
6.8%
3/44 • Number of events 4
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/24
|
11.4%
5/44 • Number of events 6
|
|
Infections and infestations
Infection
|
0.00%
0/24
|
20.5%
9/44 • Number of events 12
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/24
|
15.9%
7/44 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
0.00%
0/24
|
15.9%
7/44 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/24
|
6.8%
3/44 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Chest pain (non-cardiac and non-pleuritic)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Pain-Other (Specify, testicular)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/24
|
9.1%
4/44 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Creatinine
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Bicarbonate
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/24
|
22.7%
10/44 • Number of events 14
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/24
|
6.8%
3/44 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/24
|
6.8%
3/44 • Number of events 3
|
|
Psychiatric disorders
Mood alteration-anxiety agitation
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Neurology-Other (Specify)
|
0.00%
0/24
|
9.1%
4/44 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other (Specify, wheezing)
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
General disorders
Constitutional Symptoms-Other (Specify, generalized weakness)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
6/24 • Number of events 18
|
38.6%
17/44 • Number of events 39
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
29.2%
7/24 • Number of events 8
|
38.6%
17/44 • Number of events 43
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) for BMT studies, if specified in the protocol.
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Blood and lymphatic system disorders
Lymphopenia
|
20.8%
5/24 • Number of events 8
|
29.5%
13/44 • Number of events 25
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
20.8%
5/24 • Number of events 6
|
47.7%
21/44 • Number of events 41
|
|
Blood and lymphatic system disorders
Platelets
|
50.0%
12/24 • Number of events 27
|
75.0%
33/44 • Number of events 80
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
4.2%
1/24 • Number of events 1
|
27.3%
12/44 • Number of events 22
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
4.2%
1/24 • Number of events 1
|
29.5%
13/44 • Number of events 19
|
|
Cardiac disorders
Vasovagal episode
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
General disorders
Edema
|
4.2%
1/24 • Number of events 1
|
11.4%
5/44 • Number of events 6
|
|
Cardiac disorders
Hypotension
|
16.7%
4/24 • Number of events 7
|
25.0%
11/44 • Number of events 13
|
|
Investigations
Partial thromboplastin time (PTT)
|
12.5%
3/24 • Number of events 3
|
9.1%
4/44 • Number of events 5
|
|
Investigations
Prothrombin time (PT)
|
4.2%
1/24 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
Other adverse events
| Measure |
Part A: PS-341 Alone
n=24 participants at risk
PS-341 1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
|
Part B: PS-341 & EPOCH
n=44 participants at risk
PS-341: level 1: 0.5 mg/m\^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m\^2 IV days 1, 4; level 3: 1.5 mg/m\^2 IV days 1, 4; level 4: 1.7 mg/m\^2 IV days 1, 4.
EPOCH: Etoposide: 50 mg/m\^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m\^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m\^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m\^2 day IV day 5 bolus; Prednisone: 60 mg/m\^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm\^3. Repeat cycles every 21 days.
|
|---|---|---|
|
Investigations
Prothrombin time (PT)
|
4.2%
1/24 • Number of events 1
|
6.8%
3/44 • Number of events 5
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
4.2%
1/24 • Number of events 1
|
22.7%
10/44 • Number of events 12
|
|
General disorders
Fever
|
12.5%
3/24 • Number of events 4
|
20.5%
9/44 • Number of events 11
|
|
General disorders
Weight gain
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
1/24 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.2%
1/24 • Number of events 1
|
9.1%
4/44 • Number of events 4
|
|
Gastrointestinal disorders
Anorexia
|
29.2%
7/24 • Number of events 7
|
15.9%
7/44 • Number of events 8
|
|
Gastrointestinal disorders
Constipation
|
29.2%
7/24 • Number of events 7
|
20.5%
9/44 • Number of events 13
|
|
Gastrointestinal disorders
Dehydration
|
4.2%
1/24 • Number of events 1
|
13.6%
6/44 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
12.5%
3/24 • Number of events 6
|
13.6%
6/44 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
8.3%
2/24 • Number of events 2
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24 • Number of events 1
|
9.1%
4/44 • Number of events 4
|
|
Gastrointestinal disorders
Mouth dryness
|
8.3%
2/24 • Number of events 2
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • Number of events 4
|
29.5%
13/44 • Number of events 15
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
8.3%
2/24 • Number of events 3
|
6.8%
3/44 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
3/24 • Number of events 4
|
15.9%
7/44 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
4.2%
1/24 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hemorrhage-Other (Specify, L. eye)
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
4.2%
1/24 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
12.5%
3/24 • Number of events 3
|
9.1%
4/44 • Number of events 4
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
12.5%
3/24 • Number of events 4
|
47.7%
21/44 • Number of events 25
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4
|
4.2%
1/24 • Number of events 1
|
15.9%
7/44 • Number of events 9
|
|
Infections and infestations
Infection without neutropenia
|
20.8%
5/24 • Number of events 12
|
11.4%
5/44 • Number of events 6
|
|
Infections and infestations
Infection with unknown ANC
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Metabolism and nutrition disorders
Amylase
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
2/24 • Number of events 2
|
4.5%
2/44 • Number of events 2
|
|
Hepatobiliary disorders
Hyperglycemia
|
16.7%
4/24 • Number of events 6
|
34.1%
15/44 • Number of events 21
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
2/24 • Number of events 2
|
4.5%
2/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.2%
1/24 • Number of events 1
|
20.5%
9/44 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.2%
1/24 • Number of events 1
|
6.8%
3/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
4/24 • Number of events 5
|
36.4%
16/44 • Number of events 20
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
3/24 • Number of events 4
|
2.3%
1/44 • Number of events 1
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
4.2%
1/24 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
20.8%
5/24 • Number of events 5
|
59.1%
26/44 • Number of events 40
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
20.8%
5/24 • Number of events 5
|
56.8%
25/44 • Number of events 48
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
6/24 • Number of events 8
|
31.8%
14/44 • Number of events 22
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
8.3%
2/24 • Number of events 2
|
59.1%
26/44 • Number of events 46
|
|
Blood and lymphatic system disorders
Platelets
|
16.7%
4/24 • Number of events 10
|
31.8%
14/44 • Number of events 26
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
4.2%
1/24 • Number of events 1
|
40.9%
18/44 • Number of events 21
|
|
General disorders
Edema
|
25.0%
6/24 • Number of events 6
|
4.5%
2/44 • Number of events 3
|
|
Cardiac disorders
Phlebitis (superficial)
|
4.2%
1/24 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.2%
1/24 • Number of events 2
|
34.1%
15/44 • Number of events 24
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.3%
2/24 • Number of events 2
|
31.8%
14/44 • Number of events 20
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.2%
1/24 • Number of events 1
|
40.9%
18/44 • Number of events 24
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
4.2%
1/24 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
|
Nervous system disorders
Dizziness/lightheadedness
|
4.2%
1/24 • Number of events 1
|
9.1%
4/44 • Number of events 4
|
|
Nervous system disorders
Insomnia
|
8.3%
2/24 • Number of events 2
|
9.1%
4/44 • Number of events 4
|
|
Nervous system disorders
Neuropathy-sensory
|
8.3%
2/24 • Number of events 2
|
27.3%
12/44 • Number of events 13
|
|
Nervous system disorders
Tremor
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
25.0%
6/24 • Number of events 9
|
15.9%
7/44 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
3/24 • Number of events 4
|
18.2%
8/44 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Chest pain (non-cardiac and non-pleuritic)
|
4.2%
1/24 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2
|
9.1%
4/44 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
20.8%
5/24 • Number of events 6
|
27.3%
12/44 • Number of events 14
|
|
General disorders
Pain due to radiation
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
General disorders
Pain-Other (Specify)
|
4.2%
1/24 • Number of events 2
|
6.8%
3/44 • Number of events 3
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.3%
2/24 • Number of events 3
|
0.00%
0/44
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain (onset or exacerbation of tumor pain due to treatment)
|
8.3%
2/24 • Number of events 2
|
0.00%
0/44
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
3/24 • Number of events 4
|
9.1%
4/44 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/24
|
22.7%
10/44 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
4.2%
1/24 • Number of events 1
|
6.8%
3/44 • Number of events 3
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal-Other (Specify, degenerative changes-L. spine)
|
4.2%
1/24 • Number of events 1
|
0.00%
0/44
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
0.00%
0/24
|
6.8%
3/44 • Number of events 3
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/24
|
9.1%
4/44 • Number of events 4
|
|
Cardiac disorders
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
0.00%
0/24
|
9.1%
4/44 • Number of events 5
|
|
Cardiac disorders
Pericardial effusion/pericarditis
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Thrombosis/embolism
|
0.00%
0/24
|
6.8%
3/44 • Number of events 3
|
|
Investigations
Partial thromboplastin time (PTT)
|
0.00%
0/24
|
18.2%
8/44 • Number of events 8
|
|
General disorders
Constitutional Symptoms-Other (Specify, disease progression)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Rigors, chills
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Sweating (diaphoresis)
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
General disorders
Weight loss
|
0.00%
0/24
|
13.6%
6/44 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/24
|
13.6%
6/44 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Endocrine disorders
Hot flashes/flushes
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
0.00%
0/24
|
6.8%
3/44 • Number of events 5
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
0.00%
0/24
|
43.2%
19/44 • Number of events 26
|
|
Hepatobiliary disorders
Bilirubin
|
0.00%
0/24
|
15.9%
7/44 • Number of events 7
|
|
Hepatobiliary disorders
SGOT (aspartate aminotransferase (AST)) (serum glutamic oxaloacetic transaminase)
|
0.00%
0/24
|
9.1%
4/44 • Number of events 4
|
|
Investigations
SGPT (alanine aminotransferase (ALT)) (serum glutamic pyruvic transaminase)
|
0.00%
0/24
|
20.5%
9/44 • Number of events 11
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/24
|
13.6%
6/44 • Number of events 7
|
|
Investigations
Bicarbonate
|
0.00%
0/24
|
2.3%
1/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/24
|
15.9%
7/44 • Number of events 8
|
|
Metabolism and nutrition disorders
Lipase
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Confusion
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Mood alteration-depression
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Neurologic-Other (Specify)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
Nervous system disorders
Vertigo
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
0.00%
0/24
|
13.6%
6/44 • Number of events 8
|
|
Nervous system disorders
Neuropathic pain (e.g. jaw pain, neurologic pain, phantom pain, limb pain, post-infectious neuralgi
|
0.00%
0/24
|
4.5%
2/44 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
0.00%
0/24
|
2.3%
1/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/24
|
9.1%
4/44 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other (Specify, wheezing)
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
|
0.00%
0/24
|
4.5%
2/44 • Number of events 2
|
|
Renal and urinary disorders
Creatinine
|
0.00%
0/24
|
13.6%
6/44 • Number of events 9
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/24
|
2.3%
1/44 • Number of events 1
|
Additional Information
Wyndham Wilson, M.D.
National Cancer Institute, National Institues of Health
Phone: 301-435-2415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place