Trial Outcomes & Findings for Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom's Macroglobulinemia (NCT NCT02400437)
NCT ID: NCT02400437
Last Updated: 2020-09-02
Results Overview
Rate of very good partial response or better in patients treated with IDR. VGPR is defined as a \>90% reduction in serum IgM levels from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
76 weeks
Results posted on
2020-09-02
Participant Flow
Participant milestones
| Measure |
Ixazomib, Dexamethasone, Rituximab
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity
* Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.
* Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase
* Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase
* Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase
Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Rituximab: Doses given on Day 1 of induction and maintenance cycles.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom's Macroglobulinemia
Baseline characteristics by cohort
| Measure |
Ixazomib, Dexamethasone, Rituximab
n=26 Participants
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity
* Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.
* Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase
* Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase
* Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase
Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Rituximab: Doses given on Day 1 of induction and maintenance cycles.
|
|---|---|
|
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
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
62.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 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
|
26 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
|
26 participants
n=5 Participants
|
|
Mutational Status
MYD88 Mutated, CXCR4 Wild-type
|
11 Participants
n=5 Participants
|
|
Mutational Status
MYD88 Mutated, CXCR4 Mutated
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 76 weeksPopulation: All participants who have received at least 1 cycle of therapy.
Rate of very good partial response or better in patients treated with IDR. VGPR is defined as a \>90% reduction in serum IgM levels from baseline.
Outcome measures
| Measure |
Ixazomib, Dexamethasone, Rituximab
n=26 Participants
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity
* Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.
* Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase
* Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase
* Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase
Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Rituximab: Doses given on Day 1 of induction and maintenance cycles.
|
MYD88 Mutated, CXCR4 Mutated
Participants with both the MYD88 mutation and a CXCR4 mutation
|
|---|---|---|
|
Very Good Partial Response Rate (VGPR) for IDR
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All participants who received at least 1 cycle of therapy.
Overall response includes the rate of complete response (CR), partial response (PR), minimal response (MR), stabl disease (SD) and progressive disease (PD). Minor response is \>25%-50% reduction in serum IgM from baseline. Partial Response is (\>50-90% reduction in serum IgM from baseline. Very Good Partial Response is \>90% reduction in serum IgM from baseline. Complete Response is resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly.
Outcome measures
| Measure |
Ixazomib, Dexamethasone, Rituximab
n=26 Participants
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity
* Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.
* Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase
* Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase
* Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase
Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Rituximab: Doses given on Day 1 of induction and maintenance cycles.
|
MYD88 Mutated, CXCR4 Mutated
Participants with both the MYD88 mutation and a CXCR4 mutation
|
|---|---|---|
|
Overall Response Rate
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to time of disease progression, assessed up to 4 years after treatment startPopulation: All participants who received at least 1 cycle of therapy. Participants were followed for up to 2 years after treatment discontinuation.
Duration of time from start of treatment to disease progression. Progressive disease is defined as occurring when a \>25% increase in serum IgM and an absolute 500mg/dL increase in IgM level occurs from the lowest attained response value, or progression of clinically significant disease related symptoms.
Outcome measures
| Measure |
Ixazomib, Dexamethasone, Rituximab
n=26 Participants
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity
* Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.
* Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase
* Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase
* Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase
Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Rituximab: Doses given on Day 1 of induction and maintenance cycles.
|
MYD88 Mutated, CXCR4 Mutated
Participants with both the MYD88 mutation and a CXCR4 mutation
|
|---|---|---|
|
Progression-free Survival (PFS)
|
33 months
Interval 4.0 to 46.0
|
—
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Number of participants who achieved a response by mutational status
To evaluate the overall response rate of participants by MYD88 L265P and CXCR4-WHIM mutations in WM. Overall response is defined as achieving at least a minor response, or \>25% reduction in serum IgM from baseline.
Outcome measures
| Measure |
Ixazomib, Dexamethasone, Rituximab
n=11 Participants
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity
* Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.
* Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase
* Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase
* Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase
Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Rituximab: Doses given on Day 1 of induction and maintenance cycles.
|
MYD88 Mutated, CXCR4 Mutated
n=15 Participants
Participants with both the MYD88 mutation and a CXCR4 mutation
|
|---|---|---|
|
Overall Response Rate by MYD88 L265P and CXCR4-WHIM Status
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From start of treatment to time of disease progression, assessed up to 4 years after treatment startPopulation: All participants who received 1 cycle of treatment.
Duration of time from start of treatment to time of disease progression.
Outcome measures
| Measure |
Ixazomib, Dexamethasone, Rituximab
n=26 Participants
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity
* Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.
* Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase
* Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase
* Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase
Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Rituximab: Doses given on Day 1 of induction and maintenance cycles.
|
MYD88 Mutated, CXCR4 Mutated
Participants with both the MYD88 mutation and a CXCR4 mutation
|
|---|---|---|
|
Time to Progression (TTP)
|
33 months
Interval 4.0 to 46.0
|
—
|
SECONDARY outcome
Timeframe: From the time each participant achieved a response to time of disease progression, assessed up to 4 years after treatment startPopulation: All participants who achieved a response to therapy.
The duration of response is measured from the time a participant achieved a response until the date of progression.
Outcome measures
| Measure |
Ixazomib, Dexamethasone, Rituximab
n=25 Participants
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity
* Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.
* Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase
* Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase
* Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase
Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Rituximab: Doses given on Day 1 of induction and maintenance cycles.
|
MYD88 Mutated, CXCR4 Mutated
Participants with both the MYD88 mutation and a CXCR4 mutation
|
|---|---|---|
|
Duration of Response (DOR)
|
33 months
Interval 2.0 to 41.0
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until the participant begins a new therapy, assessed up to 4 years after treatment startDuration from start of protocol treatment to time of initiation of new therapy.
Outcome measures
| Measure |
Ixazomib, Dexamethasone, Rituximab
n=26 Participants
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity
* Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.
* Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase
* Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase
* Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase
Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Rituximab: Doses given on Day 1 of induction and maintenance cycles.
|
MYD88 Mutated, CXCR4 Mutated
Participants with both the MYD88 mutation and a CXCR4 mutation
|
|---|---|---|
|
Time to Next Therapy (TTNT)
|
39 months
Interval 4.0 to 46.0
|
—
|
Adverse Events
Ixazomib, Dexamethasone, Rituximab
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixazomib, Dexamethasone, Rituximab
n=26 participants at risk
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity
* Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.
* Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase
* Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase
* Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase
Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Rituximab: Doses given on Day 1 of induction and maintenance cycles.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Failure to thrive
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Cardiac disorders
Heart Failure
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Infections and infestations
Sepsis
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Flu-like symptoms
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Infections and infestations
Pneumonia
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Infections and infestations
Staph Aureus Bacteremia
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
Other adverse events
| Measure |
Ixazomib, Dexamethasone, Rituximab
n=26 participants at risk
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity
* Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long.
* Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase
* Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase
* Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase
Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Rituximab: Doses given on Day 1 of induction and maintenance cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Cardiac disorders
Palpitations
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Cardiac disorders
Ventricular arrhythmia
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Ear and labyrinth disorders
Ear pain
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Ear and labyrinth disorders
Hearing loss
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Eye disorders
Blurry vision
|
11.5%
3/26 • Number of events 3 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Eye disorders
Cataract
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Eye disorders
Conjunctivitis
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Eye disorders
Keratitis
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Eye disorders
Retinal detachment
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Gastrointestinal disorders
Bloating
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Gastrointestinal disorders
Constipation
|
15.4%
4/26 • Number of events 4 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
6/26 • Number of events 6 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Gastrointestinal disorders
Nausea
|
34.6%
9/26 • Number of events 9 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
4/26 • Number of events 4 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Chills
|
15.4%
4/26 • Number of events 4 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Edema face
|
11.5%
3/26 • Number of events 3 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Fatigue
|
34.6%
9/26 • Number of events 9 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Fever
|
23.1%
6/26 • Number of events 6 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Flu-like symptoms
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Feeling cold
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Sweats
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Infusion related reaction
|
34.6%
9/26 • Number of events 9 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Malaise
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
General disorders
Pain
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Infections and infestations
Pneumonia
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Infections and infestations
Skin infection
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Infections and infestations
Otitis externa
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Infections and infestations
Papulopustular rash
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Infections and infestations
Unspecified rash
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Infections and infestations
Sinusitis
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Infections and infestations
Upper respiratory infection
|
34.6%
9/26 • Number of events 9 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Investigations
Neutrophil count decreased
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Investigations
Weight gain
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Investigations
Weight loss
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.1%
6/26 • Number of events 6 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
3/26 • Number of events 3 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.5%
3/26 • Number of events 3 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Shoulder discomfort
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid nodules
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Nervous system disorders
Dizziness
|
23.1%
6/26 • Number of events 6 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Nervous system disorders
Dysgeusia
|
11.5%
3/26 • Number of events 3 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Nervous system disorders
Headache
|
11.5%
3/26 • Number of events 3 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.9%
7/26 • Number of events 7 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Nervous system disorders
Presyncope
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Nervous system disorders
Sinus pressure
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Psychiatric disorders
Insomnia
|
30.8%
8/26 • Number of events 8 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Psychiatric disorders
Restless legs
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Reproductive system and breast disorders
Amenorrhea
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.5%
3/26 • Number of events 3 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
19.2%
5/26 • Number of events 5 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Vascular disorders
Flushing
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Vascular disorders
Hematoma
|
7.7%
2/26 • Number of events 2 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Vascular disorders
Hot flashes
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • Number of events 1 • Adverse events were collected starting after the first dose of study medication through 30 days of last treatment, an average of 1.5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place