Trial Outcomes & Findings for Efficacy of Daratumumab in Patients With Relapsed/Refractory Myeloma With Renal Impairment (NCT NCT03450057)
NCT ID: NCT03450057
Last Updated: 2024-03-29
Results Overview
Progression free survival was defined as the time, in months, from treatment initiation (C1D1) to the date of the first documented disease progression or death due to any cause, whichever came first. Clinical deterioration was not considered progression. For patients who neither progressed nor died, the survival time was censored at the date of their last disease assessment. For patients who started a new anti-tumor treatment, survival time was censored at the date of the start of the new treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Duration from first daratumumab administration until death or last assessment, months.
Results posted on
2024-03-29
Participant Flow
Participant milestones
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
Overall Study
Death
|
17
|
|
Overall Study
ICF withdrawal
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Efficacy of Daratumumab in Patients With Relapsed/Refractory Myeloma With Renal Impairment
Baseline characteristics by cohort
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
n=38 Participants
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients\>75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \>75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Greek
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other European
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration from first daratumumab administration until death or last assessment, months.Population: Kaplan-Meier estimates for progression-free survival (PFS) in months.
Progression free survival was defined as the time, in months, from treatment initiation (C1D1) to the date of the first documented disease progression or death due to any cause, whichever came first. Clinical deterioration was not considered progression. For patients who neither progressed nor died, the survival time was censored at the date of their last disease assessment. For patients who started a new anti-tumor treatment, survival time was censored at the date of the start of the new treatment.
Outcome measures
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
n=38 Participants
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
The Evaluation of Progression Free Survival (PFS) in Subjects With Relapsed or Refractory Multiple Myeloma and Renal Impairment Treated With Daratumumab and Dexamethasone.
|
11.8 Months
Interval 2.8 to 20.8
|
SECONDARY outcome
Timeframe: From first dose of Daratumumab until end of treatment, PD or death (approximately up to 30 months)Overall response rate was defined as the proportion of subjects who achieve a best response of PR or better using modified IMWG criteria as their best overall response.
Outcome measures
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
n=38 Participants
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
Overall Response Rate (ORR)
|
47.4 Percent
Interval 31.5 to 63.2
|
SECONDARY outcome
Timeframe: From first dose of Daratumumab until end of treatment, PD or death (approximately up to 30 months )Renal response rate was defined as the proportion of enrolled subjects who achieve a best response of renal partial response (PRRenal) or better using the IMWG criteria.
Outcome measures
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
n=38 Participants
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
Renal Response Rate (RRR)
|
18.4 Percent
Interval 7.7 to 34.3
|
SECONDARY outcome
Timeframe: Assessed monthly from first dose of Daratumumab until PD or death from any cause (approximately up to 30 months)Duration of response was restricted to the subjects that achieve a best objective response of PR or better. It was measured from the time, in months, that the criteria for objective response are first met until the date of a progression event (according to the primary definition of PFS).
Outcome measures
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
n=18 Participants
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
Duration of Response in Patients With RI
|
28.4 Months
Interval 15.1 to
The upper limit was not reached (NR).
|
SECONDARY outcome
Timeframe: From first dose until the date to next anti-neoplastic therapy or death from any cause, whichever comes first (approximately up to 30 months)Time to next therapy was defined as the time, in months, from Cycle 1 Day 1 to the date to next anti-neoplastic therapy or death from any cause, whichever comes first.
Outcome measures
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
n=38 Participants
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
Time to Next Therapy
|
18.0 Months
Interval 5.5 to
The upper limit was never reached (NR).
|
SECONDARY outcome
Timeframe: Time from first dose of study treatment to death (approximately up to 30 months)Overall survival was defined as the time, in months, from the first dose of therapy to the date of death from any cause.
Outcome measures
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
n=38 Participants
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
Overall Survival
|
24.5 Months
Interval 5.5 to
The upper limit was never reached (NR).
|
SECONDARY outcome
Timeframe: Continuously throughout the study, starting from informed consent until 30 days after last study treatment (approximately up to 30 months).The incidence of Adverse Events and Treatment Emergent Adverse Events in patients with refractory and relapsed multiple myeloma and renal impairment treated with daratumumab with dexamethasone was assessed according to the common Terminology Criteria for Adverse Events.
Outcome measures
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
n=38 Participants
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
Any (N)SAE
|
34 Participants
|
|
To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
Any NSAE
|
32 Participants
|
|
To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
Any SAE
|
11 Participants
|
|
To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
Any (N)SADR related to daratumumab
|
7 Participants
|
|
To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
Any NSADR related to daratumumab
|
7 Participants
|
|
To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
Any SADR related to daratumumab
|
1 Participants
|
|
To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
Any (N)SAE of Grade >=3
|
24 Participants
|
|
To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
Any (N)SAE of Grade 3 or 4
|
19 Participants
|
|
To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
Any fatal SAE
|
7 Participants
|
Adverse Events
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
Serious events: 11 serious events
Other events: 32 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
n=38 participants at risk
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Infections and infestations
Peritonitis
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Infections and infestations
Pneumonia
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Infections and infestations
Septic shock
|
10.5%
4/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
Other adverse events
| Measure |
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
n=38 participants at risk
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.9%
11/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
2/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Cardiac disorders
Atrial tachycardia
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Cardiac disorders
Bradycardia
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Ear and labyrinth disorders
Ear pain
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Ear and labyrinth disorders
External ear inflammation
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.2%
5/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
2/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
General disorders
Fatigue
|
23.7%
9/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
General disorders
Influenza like illness
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
General disorders
Oedema peripheral
|
13.2%
5/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
General disorders
Pyrexia
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
General disorders
Swelling
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Infections and infestations
Osteomyelitis
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Infections and infestations
Pneumonia
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
3/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
2/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Investigations
Blood creatinine increased
|
7.9%
3/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Investigations
Neutrophil count decreased
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Investigations
Platelet count decreased
|
13.2%
5/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Investigations
Weight decreased
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.5%
4/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.8%
6/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.3%
2/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.3%
2/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
18.4%
7/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.5%
4/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Nervous system disorders
Somnolence
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Nervous system disorders
Syncope
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Psychiatric disorders
Dysphoria
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Psychiatric disorders
Insomnia
|
10.5%
4/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Psychiatric disorders
Tension
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
3/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Vascular disorders
Deep vein thrombosis
|
2.6%
1/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
|
Vascular disorders
Hypertension
|
5.3%
2/38 • 3 years.
The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
|
Additional Information
Prof. Evangelos Terpos
General Hospital of Athens 'Alexandra', Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine
Phone: +302102162540
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place