Trial Outcomes & Findings for Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors (NCT NCT05169437)
NCT ID: NCT05169437
Last Updated: 2025-10-29
Results Overview
To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to 4 years
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
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|---|---|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
|
Overall Study
STARTED
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors
Baseline characteristics by cohort
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
n=22 Participants
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Baseline Height
|
166.5 cm
STANDARD_DEVIATION 10.31 • n=5 Participants
|
|
Baseline Weight
|
74.46 kg
STANDARD_DEVIATION 19.663 • n=5 Participants
|
|
Baseline ECOG Performance Status
ECOG 0
|
7 Participants
n=5 Participants
|
|
Baseline ECOG Performance Status
ECOG 1
|
15 Participants
n=5 Participants
|
|
Cancer Type
Colon Cancer
|
4 Participants
n=5 Participants
|
|
Cancer Type
Pancreatic Carcinoma
|
4 Participants
n=5 Participants
|
|
Cancer Type
Breast Cancer
|
3 Participants
n=5 Participants
|
|
Cancer Type
Gastric Cancer
|
2 Participants
n=5 Participants
|
|
Cancer Type
Bile Duct Cancer
|
1 Participants
n=5 Participants
|
|
Cancer Type
Endometrial Cancer
|
1 Participants
n=5 Participants
|
|
Cancer Type
Glioma
|
1 Participants
n=5 Participants
|
|
Cancer Type
Malignant Melanoma
|
1 Participants
n=5 Participants
|
|
Cancer Type
Neuroendocrine Carcinoma
|
1 Participants
n=5 Participants
|
|
Cancer Type
Non-Small Cell Lung Cancer
|
1 Participants
n=5 Participants
|
|
Cancer Type
Renal Cancer
|
1 Participants
n=5 Participants
|
|
Cancer Type
Sarcoma
|
1 Participants
n=5 Participants
|
|
Cancer Type
Uterine Cancer
|
1 Participants
n=5 Participants
|
|
PALB2 Mutation Type
Germline
|
7 Participants
n=5 Participants
|
|
PALB2 Mutation Type
Somatic
|
6 Participants
n=5 Participants
|
|
PALB2 Mutation Type
Unknown
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: This endpoint was not assessed due to early study termination. Due to early study termination, data was not submitted for independent central review and therefore the overall response rate was done according to investigator assessment only and no independent central review was performed.
To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1
Outcome measures
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
Overall Response Rate (ORR) - Independent Central Review (ICR)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: This endpoint was not assessed due to early study termination. Due to early study termination, data was not submitted for independent central review and therefore the DOR was done according to investigator assessment only and no independent central review was performed.
To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1
Outcome measures
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
Duration of Response (DOR) - Independent Central Review (ICR)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: This endpoint was not assessed due to early study termination. Due to early study termination, data was not submitted for independent central review and therefore the PFS was done according to investigator assessment only and no independent central review was performed.
To evaluate progression-free survival (PFS) as assessed by ICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Outcome measures
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
Progression-Free Survival (PFS) - Independent Central Review (ICR)
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 years 3 monthsPopulation: This population consisted of all patients (12 out of 22 patients) with measurable disease who received at least 1 dose of study treatment, who had an adequate baseline tumor assessment, and at least 1 follow-up tumor assessment considered evaluable for anti-tumor efficacy using RECIST v1.1 criteria.
To evaluate ORR as defined as the proportion of patients who had a partial or complete response (PR or CR) to therapy, as assessed by Investigator using RECIST v1.1 and assessed periodically throughout the treatment period based on imaging every 8 weeks (56 ± 7 days).
Outcome measures
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
n=12 Participants
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
Overall Response Rate (ORR) - Investigator
Complete Response (CR)
|
0 Participants
|
|
Overall Response Rate (ORR) - Investigator
Partial Response (PR)
|
2 Participants
|
|
Overall Response Rate (ORR) - Investigator
Stable Disease (SD)
|
5 Participants
|
|
Overall Response Rate (ORR) - Investigator
Progressive Disease (PD)
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 years 3 monthsPopulation: This population consisted of all patients (2 patients with CR or PR out of the 12 evaluable for response, out of 22 total patients) with measurable disease who received at least 1 dose of study treatment, who had an adequate baseline tumor assessment, and at least 1 follow-up tumor assessment considered evaluable for anti-tumor efficacy using RECIST v1.1 criteria.
To evaluate DOR as assessed by Investigator using RECIST v1.1 defined as from first documentation of objective tumor response (CR or PR) to first documentation of objective tumor progression or death due to any cause.
Outcome measures
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
n=2 Participants
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
Duration of Response (DOR) - Investigator
|
NA Months
Due to early study termination, there are a lack of participant events.
|
SECONDARY outcome
Timeframe: 2 years 3 monthsPopulation: This population consisted of all patients (12 out of 22 patients) with measurable disease who received at least 1 dose of study treatment, who had an adequate baseline tumor assessment, and at least 1 follow-up tumor assessment considered evaluable for anti-tumor efficacy using RECIST v1.1 criteria.
To evaluate PFS as assessed by Investigator using RECIST v1.1 determined from the first dose to the date of first radiographic progression or death from any cause in the absence of progression, whichever occurred first, or were censored.
Outcome measures
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
n=12 Participants
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
Progression-Free Survival (PFS) - Investigator
|
3.3 Months
Interval 1.7 to
Due to early study termination, there are a lack of participant events.
|
SECONDARY outcome
Timeframe: 2 years 3 monthsPopulation: Due to early study termination, data was not submitted for independent central review and therefore the CBR was done according to investigator assessment only and no independent central review. This population consisted of all patients (12 out of 22 patients) with measurable disease who received at least 1 dose of study treatment, who had an adequate baseline tumor assessment, and at least 1 follow-up tumor assessment considered evaluable for anti-tumor efficacy using RECIST v1.1 criteria.
To evaluate Clinical Benefit Rate (CBR), defined as the percentage of patients who had achieved Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for 8 weeks or more, as assessed by Investigator only (ICR not performed due to early study termination).
Outcome measures
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
n=12 Participants
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
Clinical Benefit Rate (CBR) - Investigator and ICR
|
6 Participants
Interval 21.1 to 78.9
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: This endpoint was not assessed due to early study termination. Intracranial ORR in patients with untreated measurable CNS was not measured.
To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by Investigator using RECIST v1.1
Outcome measures
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
ORR With Untreated Measurable CNS Lesions - Investigator
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: This endpoint was not assessed due to early study termination. Due to early study termination, data was not submitted for independent central review and therefore the ORR with untreated measurable CNS lesions was not evaluated by independent central review.
To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1
Outcome measures
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
ORR With Untreated Measurable CNS Lesions - ICR
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 years 3 monthsPopulation: The Safety Population consisted of all 22 enrolled patients who took at least 1 dose of study drug.
To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Outcome measures
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
n=22 Participants
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
22 Participants
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: This population consisted of all patients (12 out of 22 patients) with measurable disease who received at least 1 dose of study treatment, who had an adequate baseline tumor assessment, and at least 1 follow-up tumor assessment considered evaluable for anti-tumor efficacy using RECIST v1.1 criteria.
To evaluate overall survival (OS) defined as the time from the date of first dose of study drug to the date of death by any cause. Patients who were alive were censored at the date of last contact.
Outcome measures
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
n=12 Participants
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
Overall Survival (OS)
Overall Survival at 6 Months
|
81.8 Percentage
Interval 44.7 to 95.1
|
|
Overall Survival (OS)
Overall Survival at 12 Months
|
51.9 Percentage
Interval 19.8 to 76.7
|
Adverse Events
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
Serious events: 6 serious events
Other events: 22 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
n=22 participants at risk
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
2/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
4.5%
1/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
4.5%
1/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
1/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
1/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
4.5%
1/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
4.5%
1/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Acidosis
|
4.5%
1/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
4.5%
1/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
n=22 participants at risk
This was a multicenter single-arm Phase-II study of niraparib in patients with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tumor PALB2 mutation (tPALB2).
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
45.5%
10/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
22.7%
5/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
4/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.6%
3/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
9.1%
2/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
9.1%
2/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
2/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
45.5%
10/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
22.7%
5/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
18.2%
4/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
13.6%
3/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
13.6%
3/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
2/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
9.1%
2/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
9.1%
2/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Investigations
Weight Decreased
|
9.1%
2/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.3%
6/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
27.3%
6/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
36.4%
8/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
18.2%
4/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
22.7%
5/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
22.7%
5/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
31.8%
7/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
2/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.7%
5/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
3/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.7%
5/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
3/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
9.1%
2/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
22.7%
5/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
13.6%
3/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
9.1%
2/22 • All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.
Population includes all patients who took at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place