Trial Outcomes & Findings for Pembrolizumab With Standard Cytotoxic Chemotherapy in Treatment Naive NSCLC Patients With Asymptomatic Brain Metastases (NCT NCT04967417)
NCT ID: NCT04967417
Last Updated: 2025-05-09
Results Overview
Intracranial objective response is defined as the investigator's best non-confirmed response as CR (complete response) or PR (partial response) as determined using RECIST v1.1. Subjects who do not meet these criteria, including those without a post-baseline tumor assessment, are considered non-responders. Intracranial objective response rate (iORR) is defined as the proportion of subjects who achieved an objective response among all subjects treated with the IP who had measurable disease at baseline. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of t the diameters of target lesion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2025-05-09
Participant Flow
Participant milestones
| Measure |
Non-squamous Cell Carcinoma
* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Pemetrexed, Carboplatin, Pembrolizumab: - Pemetrexed 500mg/m2
* Carboplatin AUC 5.0
* Pembrolizumab 200mg
|
Squamous Cell Carcinoma
* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Paclitaxel, Carboplatin, Pembrolizumab: - Paclitaxel 200mg/m2
* Caboplatin AUC 6.0
* Pembrolizumab 200mg
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
2
|
|
Overall Study
COMPLETED
|
8
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab With Standard Cytotoxic Chemotherapy in Treatment Naive NSCLC Patients With Asymptomatic Brain Metastases
Baseline characteristics by cohort
| Measure |
Non-squamous Cell Carcinoma
n=11 Participants
* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Pemetrexed, Carboplatin, Pembrolizumab: - Pemetrexed 500mg/m2
* Carboplatin AUC 5.0
* Pembrolizumab 200mg
|
Squamous Cell Carcinoma
n=2 Participants
* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Paclitaxel, Carboplatin, Pembrolizumab: - Paclitaxel 200mg/m2
* Caboplatin AUC 6.0
* Pembrolizumab 200mg
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10.75 • n=5 Participants
|
49 years
STANDARD_DEVIATION 24.04 • n=7 Participants
|
61.69 years
STANDARD_DEVIATION 13.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
11 participants
n=5 Participants
|
2 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Smoking history
Never
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Smoking history
Former
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Smoking history
Current
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsIntracranial objective response is defined as the investigator's best non-confirmed response as CR (complete response) or PR (partial response) as determined using RECIST v1.1. Subjects who do not meet these criteria, including those without a post-baseline tumor assessment, are considered non-responders. Intracranial objective response rate (iORR) is defined as the proportion of subjects who achieved an objective response among all subjects treated with the IP who had measurable disease at baseline. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of t the diameters of target lesion.
Outcome measures
| Measure |
Non-squamous Cell Carcinoma
n=11 Participants
* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Pemetrexed, Carboplatin, Pembrolizumab: - Pemetrexed 500mg/m2
* Carboplatin AUC 5.0
* Pembrolizumab 200mg
|
Squamous Cell Carcinoma
n=2 Participants
* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Paclitaxel, Carboplatin, Pembrolizumab: - Paclitaxel 200mg/m2
* Caboplatin AUC 6.0
* Pembrolizumab 200mg
|
|---|---|---|
|
Intracranial Objective Response Rate
Partial Response
|
6 Participants
|
0 Participants
|
|
Intracranial Objective Response Rate
Stable Response
|
5 Participants
|
0 Participants
|
|
Intracranial Objective Response Rate
Progressive Disease
|
0 Participants
|
1 Participants
|
|
Intracranial Objective Response Rate
Not evaluabe
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: The time until the date of either disease progression or the all-cause mortality from the date of IP administration. Up to 30 monthsPFS is defined as the period between the start date of the investigational drug and the date of the first documented disease progression or death, whichever occurs first. \- PFS (month) = (date of the first documented disease progression or death - date of the start of the investigational drug + 1) / 30.4375 Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum of diameters (nadir) on study (this includes the baseline sum if that is the smallest on study), or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Non-squamous Cell Carcinoma
n=11 Participants
* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Pemetrexed, Carboplatin, Pembrolizumab: - Pemetrexed 500mg/m2
* Carboplatin AUC 5.0
* Pembrolizumab 200mg
|
Squamous Cell Carcinoma
n=2 Participants
* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Paclitaxel, Carboplatin, Pembrolizumab: - Paclitaxel 200mg/m2
* Caboplatin AUC 6.0
* Pembrolizumab 200mg
|
|---|---|---|
|
Progression Free Survival (PFS)
|
7.23 Months
Interval 2.4 to 12.29
|
7.7 Months
Interval 1.25 to 14.16
|
SECONDARY outcome
Timeframe: The time until defined by date of all-cause mortality from the date of IP Administration. Up to 30 months.Overall survival defined by date of all-cause mortality from the date of IP Administration will be calculated.
Outcome measures
| Measure |
Non-squamous Cell Carcinoma
n=11 Participants
* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Pemetrexed, Carboplatin, Pembrolizumab: - Pemetrexed 500mg/m2
* Carboplatin AUC 5.0
* Pembrolizumab 200mg
|
Squamous Cell Carcinoma
n=2 Participants
* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Paclitaxel, Carboplatin, Pembrolizumab: - Paclitaxel 200mg/m2
* Caboplatin AUC 6.0
* Pembrolizumab 200mg
|
|---|---|---|
|
Overall Survival (OS)
|
10.45 Months
Interval 7.2 to 21.52
|
12.45 Months
Interval 10.71 to 14.19
|
SECONDARY outcome
Timeframe: Up to 30 months.Population: For squamous cell carcinoma (SCC), there was no response in a total of 2 patients.
The duration for intracranial response will be calculated separately to evaluate the intracranial efficacy of IP drug
Outcome measures
| Measure |
Non-squamous Cell Carcinoma
n=11 Participants
* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Pemetrexed, Carboplatin, Pembrolizumab: - Pemetrexed 500mg/m2
* Carboplatin AUC 5.0
* Pembrolizumab 200mg
|
Squamous Cell Carcinoma
* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Paclitaxel, Carboplatin, Pembrolizumab: - Paclitaxel 200mg/m2
* Caboplatin AUC 6.0
* Pembrolizumab 200mg
|
|---|---|---|
|
Intracranial Duration of Response
|
9.3 Months
Interval 3.98 to 20.34
|
—
|
SECONDARY outcome
Timeframe: Up to 30 months.Progression free survival of intracranial disease defined by the date of disease progression of intracranial lesion from the date of IP administration will be calculated. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum of diameters (nadir) on study (this includes the baseline sum if that is the smallest on study), or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Non-squamous Cell Carcinoma
n=11 Participants
* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Pemetrexed, Carboplatin, Pembrolizumab: - Pemetrexed 500mg/m2
* Carboplatin AUC 5.0
* Pembrolizumab 200mg
|
Squamous Cell Carcinoma
n=2 Participants
* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Paclitaxel, Carboplatin, Pembrolizumab: - Paclitaxel 200mg/m2
* Caboplatin AUC 6.0
* Pembrolizumab 200mg
|
|---|---|---|
|
Intracranial Progression-free Survival
|
9.82 Months
Interval 5.19 to 21.49
|
7.7 Months
Interval 1.25 to 14.16
|
SECONDARY outcome
Timeframe: Up to 30 months.Objective response rate is defined as the investigator's best non-confirmed response as CR (complete response) or PR (partial response) as determined using RECIST v1.1. Subjects who do not meet these criteria, including those without a post-baseline tumor assessment, are considered non-responders. objective response rate (ORR) is defined as the proportion of subjects who achieved an objective response among all subjects treated with the IP who had measurable disease at baseline. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of t the diameters of target lesion.
Outcome measures
| Measure |
Non-squamous Cell Carcinoma
n=11 Participants
* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Pemetrexed, Carboplatin, Pembrolizumab: - Pemetrexed 500mg/m2
* Carboplatin AUC 5.0
* Pembrolizumab 200mg
|
Squamous Cell Carcinoma
n=2 Participants
* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Paclitaxel, Carboplatin, Pembrolizumab: - Paclitaxel 200mg/m2
* Caboplatin AUC 6.0
* Pembrolizumab 200mg
|
|---|---|---|
|
Objective Response Rate
Partial Response
|
6 Participants
|
0 Participants
|
|
Objective Response Rate
Stable Disease
|
4 Participants
|
0 Participants
|
|
Objective Response Rate
Progressive Disease
|
1 Participants
|
1 Participants
|
|
Objective Response Rate
Not evaluable
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from the date of informed consent signature to 30 days after last drug administrationAdverse event will be evaluated using CTCAE v5.0
Outcome measures
| Measure |
Non-squamous Cell Carcinoma
n=11 Participants
* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Pemetrexed, Carboplatin, Pembrolizumab: - Pemetrexed 500mg/m2
* Carboplatin AUC 5.0
* Pembrolizumab 200mg
|
Squamous Cell Carcinoma
n=2 Participants
* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Paclitaxel, Carboplatin, Pembrolizumab: - Paclitaxel 200mg/m2
* Caboplatin AUC 6.0
* Pembrolizumab 200mg
|
|---|---|---|
|
Adverse Events
TEAEs
|
11 Number
|
2 Number
|
|
Adverse Events
ADR
|
5 Number
|
0 Number
|
|
Adverse Events
SAE
|
2 Number
|
0 Number
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 months.Population: Although this outcome was pre-specified, the study enrolled only 13 participants and valid PD-L1 expression data were available for very few participants. As such, it was not possible to conduct any meaningful exploratory analyses based on PD-L1 status. Given the limited sample size and incomplete biomarker data, this outcome was not analyzed, and no results are reported. All samples were collected and handled in accordance with participants' ICF and the protocol approved by the IRB.
The exploratory analyses based on the PD-L1 expression (by DAKO PD-L1 22C3 assay) from the baseline samples will be used for the exploratory analyses in subjects who are available for the PD-L1 test
Outcome measures
Outcome data not reported
Adverse Events
Non-squamous Cell Carcinoma
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Squamous Cell Carcinoma
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-squamous Cell Carcinoma
n=11 participants at risk
* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Pemetrexed, Carboplatin, Pembrolizumab: - Pemetrexed 500mg/m2
* Carboplatin AUC 5.0
* Pembrolizumab 200mg
|
Squamous Cell Carcinoma
n=2 participants at risk
* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Paclitaxel, Carboplatin, Pembrolizumab: - Paclitaxel 200mg/m2
* Caboplatin AUC 6.0
* Pembrolizumab 200mg
|
|---|---|---|
|
Infections and infestations
ALT Increased
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Cardiac disorders
Heart failure
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
AST increased
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Cardiac disorders
AV block complete
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Acute pyelonephritis
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Aspiration pneumonia
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
Other adverse events
| Measure |
Non-squamous Cell Carcinoma
n=11 participants at risk
* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Pemetrexed, Carboplatin, Pembrolizumab: - Pemetrexed 500mg/m2
* Carboplatin AUC 5.0
* Pembrolizumab 200mg
|
Squamous Cell Carcinoma
n=2 participants at risk
* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Paclitaxel, Carboplatin, Pembrolizumab: - Paclitaxel 200mg/m2
* Caboplatin AUC 6.0
* Pembrolizumab 200mg
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
36.4%
4/11 • Number of events 4 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Cardiac disorders
Atrioventricular block complete
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Cardiac disorders
Cardiac failure
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Cardiac disorders
Pericardial effusion
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Gastrointestinal disorders
Dyspepsia
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
General disorders
Chest pain
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
General disorders
Face oedema
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
General disorders
Mucosal inflammation
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
General disorders
Oedema
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
General disorders
Pyrexia
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Hepatobiliary disorders
Jaundice
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
COVID-19
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Herpes zoster
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Pneumonia
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Pneumonia aspiration
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Pyelonephritis acute Investigations
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Alanine aminotransferase increased
|
100.0%
11/11 • Number of events 11 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Aspartate aminotransferase increased
|
81.8%
9/11 • Number of events 9 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Blood alkaline phosphatase increased
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Blood bilirubin increased
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Blood creatine increased
|
27.3%
3/11 • Number of events 3 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Infections and infestations
Weight decreased
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
36.4%
4/11 • Number of events 4 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.3%
3/11 • Number of events 3 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
50.0%
1/2 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/11 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
50.0%
1/2 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Nervous system disorders
Paraesthesia
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Nervous system disorders
Taste disorder
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/11 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
50.0%
1/2 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/11 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
50.0%
1/2 • Number of events 1 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
45.5%
5/11 • Number of events 5 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.3%
3/11 • Number of events 3 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
0.00%
0/2 • Adverse Events were collected for 28 days (±7 days) after the final administration of the study drug, up to 24months. All-Cause Mortality was assessed through study completion, up to 30 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place