Trial Outcomes & Findings for Phase II Trial of Revlimid® and Rituximab for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) (NCT NCT01199575)
NCT ID: NCT01199575
Last Updated: 2024-08-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
nine months
Results posted on
2024-08-15
Participant Flow
Participant milestones
| Measure |
Revlimid + Rituximab
Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.
Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Revlimid + Rituximab
Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.
Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Phase II Trial of Revlimid® and Rituximab for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Baseline characteristics by cohort
| Measure |
Revlimid + Rituximab
n=30 Participants
Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.
Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: nine monthsOutcome measures
| Measure |
Revlimid + Rituximab
n=25 Participants
A: Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.
Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.
Revlimid
Rituximab
|
|---|---|
|
Overall Response Rate (ORR)
|
25 Participants
|
SECONDARY outcome
Timeframe: one yearOutcome measures
| Measure |
Revlimid + Rituximab
n=25 Participants
A: Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.
Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.
Revlimid
Rituximab
|
|---|---|
|
Adverse Events to Study Treatment
|
25 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Revlimid + Rituximab
n=25 Participants
A: Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.
Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.
Revlimid
Rituximab
|
|---|---|
|
Progression Free Survival.
|
13 Participants
|
SECONDARY outcome
Timeframe: 13 cyclesOutcome measures
| Measure |
Revlimid + Rituximab
n=25 Participants
A: Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.
Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.
Revlimid
Rituximab
|
|---|---|
|
Conversion of MRD-positive Complete Response or Partial Response (PR) to a MRD-negative Complete Response (CR) or Complete Response (CR) Respectively Following an Additional 6 Cycles of Revlimid Consolidation
|
3 Participants
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
Revlimid + Rituximab
n=25 Participants
A: Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.
Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.
Revlimid
Rituximab
|
|---|---|
|
Overall Survival
|
22 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Revlimid + Rituximab
n=25 Participants
A: Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.
Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.
Revlimid
Rituximab
|
|---|---|
|
Treatment Free Survival.
|
6 Participants
|
Adverse Events
Revlimid + Rituximab
Serious events: 11 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Revlimid + Rituximab
n=25 participants at risk
Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.
Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
neutropenia
|
28.0%
7/25 • Number of events 9
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hypophosphatemia
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Vascular disorders
Deep Vein Thrombosis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Injury, poisoning and procedural complications
Bullous arthropod reaction
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
Other adverse events
| Measure |
Revlimid + Rituximab
n=25 participants at risk
Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.
Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.
|
|---|---|
|
Renal and urinary disorders
acute renal failure
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Hepatobiliary disorders
alkaline phosphatase increase
|
28.0%
7/25 • Number of events 7
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Immune system disorders
allergic reaction
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
alopecia
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
anemia
|
64.0%
16/25 • Number of events 26
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Metabolism and nutrition disorders
anorexia
|
44.0%
11/25 • Number of events 14
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
abdominal distension
|
20.0%
5/25 • Number of events 6
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
acid reflux
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
acidosis
|
20.0%
5/25 • Number of events 5
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Social circumstances
anxiety
|
60.0%
15/25 • Number of events 29
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
20.0%
5/25 • Number of events 8
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
arthritis (gout big toe)
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Cardiac disorders
atrial fibrillation
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
bicarbonate decrease
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Infections and infestations
bladder infection
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Renal and urinary disorders
bladder spasm
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
blood biliruben increase
|
20.0%
5/25 • Number of events 6
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Eye disorders
blurred vision
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
body aches
|
8.0%
2/25 • Number of events 4
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Cardiac disorders
bradycardia
|
24.0%
6/25 • Number of events 8
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
16.0%
4/25 • Number of events 4
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Respiratory, thoracic and mediastinal disorders
bronchospasm/wheezing
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
bruising
|
16.0%
4/25 • Number of events 5
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
bursitis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
canker sore
|
12.0%
3/25 • Number of events 5
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
chills/rigors
|
60.0%
15/25 • Number of events 21
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
cognitive disturbance
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
cognitive impairment
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
confusion
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Eye disorders
conjunctivitis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
constipation
|
56.0%
14/25 • Number of events 20
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
cough
|
72.0%
18/25 • Number of events 23
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
cyst
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
dehydration
|
24.0%
6/25 • Number of events 7
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Psychiatric disorders
depression
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
diarrhea
|
56.0%
14/25 • Number of events 27
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Social circumstances
distress
|
20.0%
5/25 • Number of events 5
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
diverticulitis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
dizziness
|
44.0%
11/25 • Number of events 15
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
dry mouth
|
16.0%
4/25 • Number of events 4
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
dry skin
|
16.0%
4/25 • Number of events 4
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
dysesthia
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
dysgeusia
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
dyspepsia
|
28.0%
7/25 • Number of events 7
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
dysphagia
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
28.0%
7/25 • Number of events 7
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Renal and urinary disorders
dysuria
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Metabolism and nutrition disorders
early satiety
|
12.0%
3/25 • Number of events 3
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
ecchymosis
|
16.0%
4/25 • Number of events 4
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
edema
|
52.0%
13/25 • Number of events 14
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
edema - eyelid
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
edema - facial
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Hepatobiliary disorders
elevated ALT
|
48.0%
12/25 • Number of events 15
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Hepatobiliary disorders
elevated AST
|
60.0%
15/25 • Number of events 16
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Renal and urinary disorders
elevated creatinine
|
40.0%
10/25 • Number of events 15
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
elevated LDH
|
20.0%
5/25 • Number of events 6
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Endocrine disorders
elevated TSH
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
epistaxis
|
16.0%
4/25 • Number of events 4
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
fatigue
|
76.0%
19/25 • Number of events 28
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Infections and infestations
febrile illness
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
fever
|
56.0%
14/25 • Number of events 18
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
flatulance
|
16.0%
4/25 • Number of events 6
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Renal and urinary disorders
fluid retention
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
flu-like symptoms
|
52.0%
13/25 • Number of events 19
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
flushing
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Injury, poisoning and procedural complications
fracture
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
gait disturbance
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
gastroenteritis
|
4.0%
1/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
general muscle weakness
|
48.0%
12/25 • Number of events 18
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
GERD
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
GI Problems
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
headache
|
32.0%
8/25 • Number of events 13
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hematoma
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hematoma - retroperritoneal
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hemolysis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Injury, poisoning and procedural complications
hemorrhage - cut
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
hemorrhage - oral
|
12.0%
3/25 • Number of events 3
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
hemorrhage - rectal
|
4.0%
1/25 • Number of events 3
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
high cholesterol
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
hoarseness
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
hot flashes
|
12.0%
3/25 • Number of events 6
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Renal and urinary disorders
hydronephrosis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hypercalcemia
|
8.0%
2/25 • Number of events 5
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
hyperhidrosis
|
56.0%
14/25 • Number of events 17
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hyperkalemia
|
28.0%
7/25 • Number of events 7
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hypermagnesemia
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hypernatremia
|
4.0%
1/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hyperphosphatemia
|
48.0%
12/25 • Number of events 19
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Vascular disorders
hypertension
|
16.0%
4/25 • Number of events 4
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hyperuricemia
|
28.0%
7/25 • Number of events 15
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hypoalbuminemia
|
32.0%
8/25 • Number of events 9
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hypocalcemia
|
80.0%
20/25 • Number of events 30
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hypokalemia
|
12.0%
3/25 • Number of events 6
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hypomagnesemia
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hyponatremia
|
60.0%
15/25 • Number of events 25
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
hypophosphatemia
|
60.0%
15/25 • Number of events 23
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Vascular disorders
hypotension
|
32.0%
8/25 • Number of events 10
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Endocrine disorders
hypothyroidism
|
4.0%
1/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Injury, poisoning and procedural complications
infusion reaction - cytokine release syndrome
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
insomnia
|
56.0%
14/25 • Number of events 23
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
keratosis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
keratosis - actinic keratosis
|
4.0%
1/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Infections and infestations
laryngitis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
lesion
|
20.0%
5/25 • Number of events 5
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
leukopenia
|
4.0%
1/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
libido decrease
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
low uric acid
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
lumbar disc disease
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
memory impairment
|
12.0%
3/25 • Number of events 3
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
56.0%
14/25 • Number of events 22
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
nausea
|
64.0%
16/25 • Number of events 23
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
neuropathy
|
40.0%
10/25 • Number of events 13
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
neuropathy - leg and finger spasms
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
neutropenia
|
88.0%
22/25 • Number of events 42
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
night sweats
|
56.0%
14/25 • Number of events 20
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
osteopenia
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - abdominal
|
40.0%
10/25 • Number of events 14
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
pain - abdominal/stomach - cramps
|
4.0%
1/25 • Number of events 3
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - back
|
44.0%
11/25 • Number of events 18
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - chest
|
16.0%
4/25 • Number of events 5
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - chest - non-cardiac
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - ear
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - extremity
|
56.0%
14/25 • Number of events 19
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - eye
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - facial
|
4.0%
1/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - hip
|
16.0%
4/25 • Number of events 6
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - knee
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - lymph node
|
12.0%
3/25 • Number of events 3
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - neck
|
8.0%
2/25 • Number of events 3
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - pharyngolaryngeal
|
48.0%
12/25 • Number of events 14
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - rectal
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - ribs
|
4.0%
1/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - right disessciata
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - right side
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
pain - skin
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - stomach
|
36.0%
9/25 • Number of events 12
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
pain - tumor
|
48.0%
12/25 • Number of events 16
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Injury, poisoning and procedural complications
palmar-plantar erythrodysesthia
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Cardiac disorders
palpitations
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Reproductive system and breast disorders
prostatitis
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Renal and urinary disorders
proteinuria
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
pruritis
|
40.0%
10/25 • Number of events 16
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Psychiatric disorders
psychosis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Vascular disorders
purpura
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
rash
|
60.0%
15/25 • Number of events 24
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
restless leg syndrome
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Eye disorders
retinal detachment
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
rhinitis
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Immune system disorders
rhinitis - allergic rhinitis
|
44.0%
11/25 • Number of events 16
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Eye disorders
right eye floater
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
sciatica
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Cardiac disorders
sinus arrhythmia
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Infections and infestations
sinusitis
|
20.0%
5/25 • Number of events 8
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous tissue disorder
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
skin hyperpigmentation
|
20.0%
5/25 • Number of events 5
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
skin infection
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
skin infection - cellulitis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
skin ulceration
|
12.0%
3/25 • Number of events 4
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
skin ulceration - blister on roof of mouth
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
skin ulceration - finger
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
small intestine infection
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Vascular disorders
superficial phlebitis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
swelling - tongue
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
General disorders
syncope
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Cardiac disorders
tachycardia
|
12.0%
3/25 • Number of events 3
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
taste alteration
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Musculoskeletal and connective tissue disorders
tendonitis
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
80.0%
20/25 • Number of events 28
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Vascular disorders
thrombophlebitis
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Vascular disorders
thrombophlebitis - superficial
|
16.0%
4/25 • Number of events 7
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Ear and labyrinth disorders
tinnitus
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Nervous system disorders
tremors
|
12.0%
3/25 • Number of events 3
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Injury, poisoning and procedural complications
tumor flare reaction
|
12.0%
3/25 • Number of events 5
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
ulcer - mouth
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Infections and infestations
Upper Respiratory Infection
|
52.0%
13/25 • Number of events 16
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Renal and urinary disorders
urinary frequency
|
40.0%
10/25 • Number of events 12
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Renal and urinary disorders
urinary retention
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Renal and urinary disorders
urinary tract infection
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Renal and urinary disorders
urine discoloration
|
8.0%
2/25 • Number of events 2
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Renal and urinary disorders
urine odor
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Skin and subcutaneous tissue disorders
urticaria
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Reproductive system and breast disorders
vaginal odor
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Cardiac disorders
ventricular arrhythmia
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Gastrointestinal disorders
vomiting
|
32.0%
8/25 • Number of events 9
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Eye disorders
watering eyes
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Metabolism and nutrition disorders
weight gain
|
4.0%
1/25 • Number of events 1
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Metabolism and nutrition disorders
weight loss
|
60.0%
15/25 • Number of events 18
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
|
Reproductive system and breast disorders
yeast (vaginal) infection
|
4.0%
1/25 • Number of events 3
standard questionnaire, regular investigator assessment, regular laboratory testing, or other method
|
Additional Information
Thomas Kipps, MD PhD
University of California, San Diego
Phone: 858-534-5400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place