Trial Outcomes & Findings for Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer (NCT NCT03759587)
NCT ID: NCT03759587
Last Updated: 2024-06-07
Results Overview
An adverse event of 'thrombocytopenia' was collected and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03.As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 30 days after the first dose
Results posted on
2024-06-07
Participant Flow
Participants took part in the study at 27 investigative sites in Japan from 28 December 2018 to 28 December 2022.
Participants with a diagnosis of with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, who had achieved complete response (CR) or partial response (PR) in the last chemotherapy containing platinum-based anticancer agents were enrolled to received niraparib 300 mg in this study.
Participant milestones
| Measure |
Niraparib 300 mg
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
Response Evaluable Set
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Niraparib 300 mg
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Progressive Disease
|
10
|
|
Overall Study
Site Terminated by Sponsor
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Number analyzed is the number of participants with sites of metastatic disease at baseline.
Baseline characteristics by cohort
| Measure |
Niraparib 300 mg
n=19 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 9.64 • n=19 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
|
Region of Enrollment
Japan
|
19 Participants
n=19 Participants
|
|
Height
|
156.7 cm
STANDARD_DEVIATION 4.82 • n=19 Participants
|
|
Weight
|
57.47 kg
STANDARD_DEVIATION 10.445 • n=19 Participants
|
|
Body Mass Index (BMI)
|
23.46 kg/m^2
STANDARD_DEVIATION 4.471 • n=19 Participants
|
|
Breast Cancer (Gene) (BRCA1) Mutant
Without Mutant
|
1 Participants
n=19 Participants
|
|
Breast Cancer (Gene) (BRCA1) Mutant
Unknown
|
18 Participants
n=19 Participants
|
|
BRCA2 Mutant
Without Mutant
|
1 Participants
n=19 Participants
|
|
BRCA2 Mutant
Unknown
|
18 Participants
n=19 Participants
|
|
Time to Progression after the Penultimate (Next to Last) Platinum Therapy
6-12 Months
|
5 Participants
n=19 Participants
|
|
Time to Progression after the Penultimate (Next to Last) Platinum Therapy
More Than 12 Months
|
14 Participants
n=19 Participants
|
|
Best Response during the Last Platinum Regimen
Complete Response (CR)
|
8 Participants
n=19 Participants
|
|
Best Response during the Last Platinum Regimen
Partial Response (PR)
|
11 Participants
n=19 Participants
|
|
Time from Last Platinum Therapy to Start of Study Drug (days)
|
42.0 days
n=19 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
17 Participants
n=19 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
2 Participants
n=19 Participants
|
|
Primary Tumor Site
Ovarian
|
10 Participants
n=19 Participants
|
|
Primary Tumor Site
Primary Peritoneal
|
5 Participants
n=19 Participants
|
|
Primary Tumor Site
Fallopian Tube
|
4 Participants
n=19 Participants
|
|
Duration Since Initial Diagnosis of Primary Cancer
|
3.35 years
n=19 Participants
|
|
Cancer Stage at Time of Initial Diagnosis
IC
|
1 Participants
n=19 Participants
|
|
Cancer Stage at Time of Initial Diagnosis
IIC
|
1 Participants
n=19 Participants
|
|
Cancer Stage at Time of Initial Diagnosis
IIIB
|
2 Participants
n=19 Participants
|
|
Cancer Stage at Time of Initial Diagnosis
IIIC
|
10 Participants
n=19 Participants
|
|
Cancer Stage at Time of Initial Diagnosis
IV
|
4 Participants
n=19 Participants
|
|
Cancer Stage at Time of Initial Diagnosis
Unknown
|
1 Participants
n=19 Participants
|
|
Sites of Metastatic Disease
Ascites or pleural effusion
|
1 Participants
n=8 Participants • Number analyzed is the number of participants with sites of metastatic disease at baseline.
|
|
Sites of Metastatic Disease
Peritoneum
|
4 Participants
n=8 Participants • Number analyzed is the number of participants with sites of metastatic disease at baseline.
|
|
Sites of Metastatic Disease
Lymph Nodes
|
1 Participants
n=8 Participants • Number analyzed is the number of participants with sites of metastatic disease at baseline.
|
|
Sites of Metastatic Disease
Other
|
2 Participants
n=8 Participants • Number analyzed is the number of participants with sites of metastatic disease at baseline.
|
|
Number of Metastatic Sites
|
1.0 metastatic Sites
STANDARD_DEVIATION 0.00 • n=8 Participants • Number analyzed is the number of participants with sites of metastatic disease.
|
|
Prior Radiation Therapy
Had Radiation Therapy
|
1 Participants
n=19 Participants
|
|
Prior Radiation Therapy
Had No Radiation Therapy
|
18 Participants
n=19 Participants
|
|
Prior Surgery/Procedure
Had Surgery/ Procedure
|
19 Participants
n=19 Participants
|
|
Prior Chemotherapy
Had Chemotherapy
|
19 Participants
n=19 Participants
|
|
Number of Prior Surgery/Procedure for Study Indication
|
2.3 number of surgery
STANDARD_DEVIATION 1.38 • n=19 Participants
|
|
Prior History of Myelosuppression
Had Myelosuppression
|
19 Participants
n=19 Participants
|
|
Prior Thrombocytopenia
Grade 1
|
12 Participants
n=18 Participants • Number analyzed is the number of participants with prior thrombocytopenia at baseline.
|
|
Prior Thrombocytopenia
Grade 2
|
2 Participants
n=18 Participants • Number analyzed is the number of participants with prior thrombocytopenia at baseline.
|
|
Prior Thrombocytopenia
Grade 3
|
3 Participants
n=18 Participants • Number analyzed is the number of participants with prior thrombocytopenia at baseline.
|
|
Prior Thrombocytopenia
Grade 4
|
1 Participants
n=18 Participants • Number analyzed is the number of participants with prior thrombocytopenia at baseline.
|
|
Prior Leukopenia
Grade 2
|
6 Participants
n=16 Participants • Number analyzed is the number of participants with prior leukopenia at baseline.
|
|
Prior Leukopenia
Grade 3
|
9 Participants
n=16 Participants • Number analyzed is the number of participants with prior leukopenia at baseline.
|
|
Prior Leukopenia
Grade 4
|
1 Participants
n=16 Participants • Number analyzed is the number of participants with prior leukopenia at baseline.
|
|
Prior Anemia
Grade 1
|
1 Participants
n=17 Participants • Number analyzed is the number of participants with prior anemia at baseline.
|
|
Prior Anemia
Grade 2
|
5 Participants
n=17 Participants • Number analyzed is the number of participants with prior anemia at baseline.
|
|
Prior Anemia
Grade 3
|
11 Participants
n=17 Participants • Number analyzed is the number of participants with prior anemia at baseline.
|
|
Prior Neutropenia
Grade 2
|
1 Participants
n=19 Participants
|
|
Prior Neutropenia
Grade 3
|
6 Participants
n=19 Participants
|
|
Prior Neutropenia
Grade 4
|
12 Participants
n=19 Participants
|
|
Baseline Platelets Count
|
214.1 10^9 platelets/L
STANDARD_DEVIATION 58.06 • n=19 Participants
|
|
Ovarian Cancer Pathology Histological
|
19 Participants
n=19 Participants
|
|
Tumor Grade
Grade 3
|
5 Participants
n=19 Participants
|
|
Tumor Grade
Higher Grade
|
14 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after the first dosePopulation: Safety Analysis Set included participants who received at least 1 dose of study drug.
An adverse event of 'thrombocytopenia' was collected and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03.As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE).
Outcome measures
| Measure |
Niraparib 300 mg
n=19 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Number of Participants With Grade 3 or 4 Thrombocytopenia Occurring Within 30 Days After Initial Administration of Niraparib
|
6 Participants
|
SECONDARY outcome
Timeframe: From the day of signing the informed consent form (ICF) until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).Population: Safety Analysis Set included participants who received at least 1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Niraparib 300 mg
n=19 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
19 Participants
|
SECONDARY outcome
Timeframe: From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).Population: Safety Analysis Set included participants who received at least 1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A severity grade is defined by the NCI-CTCAE Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Outcome measures
| Measure |
Niraparib 300 mg
n=19 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Number of Participants With Grade 3 or Higher TEAEs
|
14 Participants
|
SECONDARY outcome
Timeframe: From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).Population: Safety Analysis Set included participants who received at least 1 dose of study drug.
An SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Outcome measures
| Measure |
Niraparib 300 mg
n=19 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
4 Participants
|
SECONDARY outcome
Timeframe: From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).Population: Safety Analysis Set included participants who received at least 1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Niraparib 300 mg
n=19 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Number of Participants With TEAEs Leading to Drug Discontinuation
|
5 Participants
|
SECONDARY outcome
Timeframe: From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).Population: Safety Analysis Set included participants who received at least 1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Niraparib 300 mg
n=19 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Number of Participants With TEAEs Leading to Dose Interruption
|
16 Participants
|
SECONDARY outcome
Timeframe: From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).Population: Safety Analysis Set included participants who received at least 1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Niraparib 300 mg
n=19 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Number of Participants With TEAEs Leading to Dose Reduction
|
16 Participants
|
SECONDARY outcome
Timeframe: From first study drug administration until disease progression or death (up to 48 months)Population: Full Analysis Set included participants who received at least 1 dose of study drug.
PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST 1.1, PD is defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Niraparib 300 mg
n=19 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Progression Free Survival (PFS)
|
18 months
Interval 1.8 to 46.0
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Full Analysis Set included participants who received at least 1 dose of study drug.
OS is defined as the time from the study enrollment to death due to any cause.
Outcome measures
| Measure |
Niraparib 300 mg
n=19 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Overall Survival (OS)
|
NA months
Interval 14.3 to 47.0
Median was not estimable due to low number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Response-evaluable Analysis Set included participants who received at least 1 dose of study drug and had at least one measurable disease at baseline. The data is reported only for responders.
ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as disappearance of all target lesions; PR is defined as atleast 30% decrease in sum of diameters (SoD) of target lesions.
Outcome measures
| Measure |
Niraparib 300 mg
n=5 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Overall Response Rate (ORR)
|
0 percentage of participants
|
Adverse Events
Niraparib 300mg
Serious events: 4 serious events
Other events: 19 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Niraparib 300mg
n=19 participants at risk
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Hepatobiliary disorders
Bile duct stone
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Niraparib 300mg
n=19 participants at risk
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
|
|---|---|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness postural
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Head discomfort
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
36.8%
7/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site extravasation
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Intercostal neuralgia
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Laryngitis
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
26.3%
5/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
31.6%
6/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
73.7%
14/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.8%
3/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count decreased
|
57.9%
11/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Occult blood
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral herpes
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Palpitations
|
15.8%
3/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Periodontal disease
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngitis
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Platelet count decreased
|
63.2%
12/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Skin infection
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
26.3%
5/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Tachycardia
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Thirst
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tinea infection
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
47.4%
9/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Vulvitis
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight decreased
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count decreased
|
36.8%
7/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.8%
3/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
21.1%
4/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
47.4%
9/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Angular cheilitis
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.8%
3/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.1%
4/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
15.8%
3/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Catheter site thrombosis
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Cheilitis
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Contrast media allergy
|
21.1%
4/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cystitis
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
47.4%
9/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Product Issues
Device breakage
|
5.3%
1/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.5%
2/19 • From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER