Trial Outcomes & Findings for Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI (NCT NCT00363649)
NCT ID: NCT00363649
Last Updated: 2018-11-13
Results Overview
Number of patients alive and without disease progression or relapse
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
1 year after treatment has been stopped
Results posted on
2018-11-13
Participant Flow
Two participants were screen failures.
Participant milestones
| Measure |
Arm A
Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Interferon alfa: Given by injection
Sargramostim: Given by injection
|
Arm B
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
GM-K562 cell vaccine: Given by injection
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
Crossed Over to Arm B
|
9
|
0
|
|
Overall Study
Crossed Over to Arm A
|
0
|
12
|
|
Overall Study
Did Not Cross Over
|
2
|
3
|
|
Overall Study
COMPLETED
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
Arm A
Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Interferon alfa: Given by injection
Sargramostim: Given by injection
|
Arm B
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
GM-K562 cell vaccine: Given by injection
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
6
|
0
|
Baseline Characteristics
Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI
Baseline characteristics by cohort
| Measure |
Arm A
n=18 Participants
Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Interferon alfa: Given by injection
Sargramostim: Given by injection
|
Arm B
n=16 Participants
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
GM-K562 cell vaccine: Given by injection
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43 years
n=5 Participants
|
40 years
n=7 Participants
|
40.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year after treatment has been stoppedPopulation: Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.
Number of patients alive and without disease progression or relapse
Outcome measures
| Measure |
Arm A
n=18 Participants
Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Interferon alfa: Given by injection
Sargramostim: Given by injection
|
Arm B
n=16 Participants
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
GM-K562 cell vaccine: Given by injection
|
|---|---|---|
|
Progression-free Survival
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.
Percentage of patients who achieved molecular remission as defined by polymerase chain reaction negativity.
Outcome measures
| Measure |
Arm A
n=18 Participants
Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Interferon alfa: Given by injection
Sargramostim: Given by injection
|
Arm B
n=16 Participants
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
GM-K562 cell vaccine: Given by injection
|
|---|---|---|
|
Complete Remission Rate
|
61.1 percentage of participants
|
62.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 27 monthsPopulation: Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.
Number of months from randomization to molecular remission as defined by polymerase chain reaction negativity.
Outcome measures
| Measure |
Arm A
n=18 Participants
Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Interferon alfa: Given by injection
Sargramostim: Given by injection
|
Arm B
n=16 Participants
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
GM-K562 cell vaccine: Given by injection
|
|---|---|---|
|
Time to Complete Molecular Remission
|
10 months
Interval 4.7 to 11.2
|
16.3 months
Interval 6.9 to 27.0
|
SECONDARY outcome
Timeframe: Up to 8 yearsPopulation: Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.
Median number of days to progression of disease in participants who stopped all treatment as directed by the protocol.
Outcome measures
| Measure |
Arm A
n=18 Participants
Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Interferon alfa: Given by injection
Sargramostim: Given by injection
|
Arm B
n=16 Participants
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
GM-K562 cell vaccine: Given by injection
|
|---|---|---|
|
Disease-free Survival
|
82 days
Interval 28.0 to 2924.0
|
98 days
Interval 56.0 to 116.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: This outcome includes all participants who were either started on an arm or crossed over to an arm.
Number of participants unable to complete protocol-specified treatment due to toxicity.
Outcome measures
| Measure |
Arm A
n=30 Participants
Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Interferon alfa: Given by injection
Sargramostim: Given by injection
|
Arm B
n=25 Participants
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
GM-K562 cell vaccine: Given by injection
|
|---|---|---|
|
Early Discontinuation
|
10 Participants
|
0 Participants
|
Adverse Events
Arm A
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Arm B
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=30 participants at risk
Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Interferon alfa: Given by injection
Sargramostim: Given by injection
|
Arm B
n=25 participants at risk
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
GM-K562 cell vaccine: Given by injection
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
0.00%
0/25 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New malignancy - breast cancer
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
0.00%
0/25 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
Other adverse events
| Measure |
Arm A
n=30 participants at risk
Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Interferon alfa: Given by injection
Sargramostim: Given by injection
|
Arm B
n=25 participants at risk
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
GM-K562 cell vaccine: Given by injection
|
|---|---|---|
|
Gastrointestinal disorders
Acid reflux
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Immune system disorders
Adenopathy
|
16.7%
5/30 • Number of events 5 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Immune system disorders
Allergic reaction
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Alopecia
|
13.3%
4/30 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
ALT increased
|
26.7%
8/30 • Number of events 17 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 5 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
Anemia
|
20.0%
6/30 • Number of events 12 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
20.0%
5/25 • Number of events 7 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Anorexia
|
20.0%
6/30 • Number of events 7 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
0.00%
0/25 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
AST increased
|
23.3%
7/30 • Number of events 10 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
32.0%
8/25 • Number of events 13 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
10.0%
3/30 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Chills
|
6.7%
2/30 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Eye disorders
Conjunctivitis
|
6.7%
2/30 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
4/30 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
24.0%
6/25 • Number of events 7 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Dehydration
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Psychiatric disorders
Depression
|
6.7%
2/30 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Gastrointestinal disorders
Diarrhea
|
23.3%
7/30 • Number of events 11 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
16.0%
4/25 • Number of events 6 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30 • Number of events 5 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
4/30 • Number of events 5 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Blood and lymphatic system disorders
Edema
|
40.0%
12/30 • Number of events 19 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
40.0%
10/25 • Number of events 17 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Fatigue
|
63.3%
19/30 • Number of events 32 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
60.0%
15/25 • Number of events 34 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Infections and infestations
Fever
|
16.7%
5/30 • Number of events 9 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
20.0%
5/25 • Number of events 8 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Flu-like symptoms
|
60.0%
18/30 • Number of events 28 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
24.0%
6/25 • Number of events 8 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Infections and infestations
Gastroenteritis
|
13.3%
4/30 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
20.0%
5/25 • Number of events 5 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Blood and lymphatic system disorders
Hidradentitis
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
Hyperglycemia
|
20.0%
6/30 • Number of events 10 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
20.0%
5/25 • Number of events 6 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Cardiac disorders
Hypertension
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
Hyperuricemia
|
13.3%
4/30 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
Hypoalbuminemia
|
10.0%
3/30 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
0.00%
0/25 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
Hypocalcemia
|
20.0%
6/30 • Number of events 8 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
Hypoglycemia
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
Hypokalemia
|
13.3%
4/30 • Number of events 8 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Gastrointestinal disorders
Indigestion
|
6.7%
2/30 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
0.00%
0/25 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
16.0%
4/25 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Immune system disorders
Injection site reaction
|
50.0%
15/30 • Number of events 23 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
100.0%
25/25 • Number of events 426 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Infections and infestations
Infection - sinus
|
16.7%
5/30 • Number of events 7 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
36.0%
9/25 • Number of events 12 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Infections and infestations
Infection - upper respiratory
|
10.0%
3/30 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
16.0%
4/25 • Number of events 6 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Insomnia
|
20.0%
6/30 • Number of events 6 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
0.00%
0/25 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Skin and subcutaneous tissue disorders
Itching
|
6.7%
2/30 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
0.00%
0/25 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
Leukopenia
|
16.7%
5/30 • Number of events 14 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
32.0%
8/25 • Number of events 15 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/30 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
Lymphopenia
|
23.3%
7/30 • Number of events 11 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Malaise
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Reproductive system and breast disorders
Menstrual cycle changes
|
13.3%
4/30 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Nervous system disorders
Migraine
|
0.00%
0/30 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.3%
7/30 • Number of events 9 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
3/30 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
28.0%
7/25 • Number of events 9 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal drip
|
6.7%
2/30 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Gastrointestinal disorders
Nausea
|
36.7%
11/30 • Number of events 11 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
20.0%
5/25 • Number of events 5 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Night sweats
|
10.0%
3/30 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Gastrointestinal disorders
Pain - abdomen
|
10.0%
3/30 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
16.7%
5/30 • Number of events 7 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
0.00%
0/25 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Musculoskeletal and connective tissue disorders
Pain - bone
|
10.0%
3/30 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 8 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Pain - ear
|
6.7%
2/30 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
0.00%
0/25 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Pain - generalized
|
13.3%
4/30 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
12.0%
3/25 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Pain - head
|
26.7%
8/30 • Number of events 12 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
32.0%
8/25 • Number of events 19 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Musculoskeletal and connective tissue disorders
Pain - leg
|
20.0%
6/30 • Number of events 8 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
0.00%
0/25 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Gastrointestinal disorders
Pain - throat
|
13.3%
4/30 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
28.0%
7/25 • Number of events 9 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Post-nasal drip
|
3.3%
1/30 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Skin and subcutaneous tissue disorders
Eye swelling
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
10/30 • Number of events 12 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
24.0%
6/25 • Number of events 6 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Rigors
|
6.7%
2/30 • Number of events 5 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
0.00%
0/25 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Immune system disorders
Seasonal allergies
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Musculoskeletal and connective tissue disorders
Ankle sprain
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Investigations
Thrombocytopenia
|
13.3%
4/30 • Number of events 9 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Infections and infestations
Viral infection
|
6.7%
2/30 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
16.0%
4/25 • Number of events 4 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Eye disorders
Watery eyes
|
6.7%
2/30 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 3 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Nervous system disorders
Weakness
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
General disorders
Weight gain
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Skin and subcutaneous tissue disorders
Xerosis
|
3.3%
1/30 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
4.0%
1/25 • Number of events 1 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
|
Gastrointestinal disorders
Xerostomia
|
6.7%
2/30 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
8.0%
2/25 • Number of events 2 • Up to 2 years
Adverse events were collected monthly for up to two years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place