Trial Outcomes & Findings for Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NCT NCT00998946)
NCT ID: NCT00998946
Last Updated: 2021-11-05
Results Overview
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR). Tumor response was evaluated on the basis of clinical and radiological criteria, assessed according to International Workshop Criteria (IWC) with or without positron emission tomography (PET) scans. Per IWC criteria CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to non-Hodgkin's lymphoma (NHL) and PR is defined as \>= 50% decrease in sum of the product of the perpendicular diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in size of other nodes, liver or spleen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2021-11-05
Participant Flow
Participant milestones
| Measure |
Pralatrexate
Participants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.
Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
Safety Population
|
27
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Pralatrexate
Participants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.
Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Reason Unspecified
|
3
|
|
Overall Study
Enrolled but not Dosed
|
2
|
Baseline Characteristics
Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Pralatrexate
n=27 Participants
Participants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.
Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
|
|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 14.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Efficacy Evaluable Population included participants who received at least 1 dose of protocol specified treatment and had measurable disease at baseline to be considered evaluable.
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR). Tumor response was evaluated on the basis of clinical and radiological criteria, assessed according to International Workshop Criteria (IWC) with or without positron emission tomography (PET) scans. Per IWC criteria CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to non-Hodgkin's lymphoma (NHL) and PR is defined as \>= 50% decrease in sum of the product of the perpendicular diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in size of other nodes, liver or spleen.
Outcome measures
| Measure |
Pralatrexate
n=27 Participants
Participants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.
Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
|
|---|---|
|
Objective Response Rate (ORR)
|
4 percentage of participants
Interval 0.0 to 19.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Efficacy Evaluable Population included participants who received at least 1 dose of protocol specified treatment and had measurable disease at baseline to be considered evaluable.
The Duration of Response was defined as the time (in months) from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was assessed according to IWC with or without PET, subject to its availability. Per IWC, progression was defined as a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.
Outcome measures
| Measure |
Pralatrexate
n=27 Participants
Participants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.
Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
|
|---|---|
|
Duration of Response (DOR)
|
NA months
Median, upper limit and lower limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Efficacy Evaluable Population included participants who received at least 1 dose of protocol specified treatment and had measurable disease at baseline to be considered evaluable.
Progression-free survival (PFS) was the duration of time (in months) from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWC with or without PET scans, subject to their availability. Per IWC, progression was defined as a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.
Outcome measures
| Measure |
Pralatrexate
n=27 Participants
Participants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.
Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
|
|---|---|
|
Progression Free Survival (PFS)
|
3.6 months
Interval 1.9 to 3.7
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Efficacy Evaluable Population included participants who received at least 1 dose of protocol specified treatment and had measurable disease at baseline to be considered evaluable.
Overall Survival was the time (in months) from first administration of study treatment until the date of death.
Outcome measures
| Measure |
Pralatrexate
n=27 Participants
Participants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.
Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
|
|---|---|
|
Overall Survival (OS)
|
NA months
Interval 7.4 to
Median and upper limit of 95% CI was not estimable due to insufficient number of participants with event.
|
Adverse Events
Pralatrexate
Serious events: 11 serious events
Other events: 27 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Pralatrexate
n=27 participants at risk
Participants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.
Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
|
|---|---|
|
Infections and infestations
Pneumonia
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Progression
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sinus Headache
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental Status Changes
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Inflammation
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutopenia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear Pain
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
18.5%
5/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Catheter Related Infection
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Pralatrexate
n=27 participants at risk
Participants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.
Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
|
|---|---|
|
Gastrointestinal disorders
Oral pain
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctitis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Saliva altered
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
59.3%
16/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
6/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
14.8%
4/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Early satiety
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
77.8%
21/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Gait disturbance
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
11.1%
3/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
22.2%
6/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
11.1%
3/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
25.9%
7/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
11.1%
3/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Catheter related infection
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Laryngitis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral rhinitis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Open wound
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
11.1%
3/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood urea increased
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Urine output decreased
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
11.1%
3/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.8%
4/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid retention
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.1%
3/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.8%
4/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Aphonia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Burning sensation
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sinus headache
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomina
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
11.1%
3/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Oliguria
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary tract pain
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.5%
5/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.8%
4/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.2%
6/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
22.2%
6/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.8%
4/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypertension
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.9%
7/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
40.7%
11/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.8%
4/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
48.1%
13/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Dry eye
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
6/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Consitpation
|
25.9%
7/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.9%
7/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.4%
2/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
44.4%
12/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral discomfort
|
3.7%
1/27 • Up to 24 months
Safety Population included all participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place