Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer (NCT NCT03574779)
NCT ID: NCT03574779
Last Updated: 2025-07-15
Results Overview
Number of Participants enrolled across cohorts are presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
Day 1
Results posted on
2025-07-15
Participant Flow
This master record includes screening phase data for participants of the sub-studies 213357-COHORT-A (NCT05751629) and 213357-COHORT-C (NCT06964165). Results are presented separately for each sub study.
A total of 173 participants started the overall study, which included all the screened participants who signed an ICF prior to enrollment. However, only 77 met the eligibility criteria and were enrolled in the study.
Participant milestones
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly (adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were screened and enrolled in Cohort A sub-study to receive Dostarlimab + Bevacizumab + Niraparib.
|
Cohort C (Niraparib OR Platinum-taxane)
Participants with ovarian cancer were screened and enrolled in Cohort C sub-study to receive either Niraparib OR Platinum-taxane.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
119
|
|
Overall Study
COMPLETED
|
41
|
36
|
|
Overall Study
NOT COMPLETED
|
13
|
83
|
Reasons for withdrawal
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly (adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were screened and enrolled in Cohort A sub-study to receive Dostarlimab + Bevacizumab + Niraparib.
|
Cohort C (Niraparib OR Platinum-taxane)
Participants with ovarian cancer were screened and enrolled in Cohort C sub-study to receive either Niraparib OR Platinum-taxane.
|
|---|---|---|
|
Overall Study
Screening failure
|
13
|
83
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=54 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly (adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were screened and enrolled in Cohort A sub-study to receive Dostarlimab + Bevacizumab + Niraparib.
|
Cohort C (Niraparib OR Platinum-taxane)
n=119 Participants
Participants with ovarian cancer were screened and enrolled in Cohort C sub-study to receive either Niraparib OR Platinum-taxane.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-64 years
|
25 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Age, Customized
Over 64 years
|
29 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The screened population includes all the screened participants who signed an ICF to determine their eligibility for the study.
Number of Participants enrolled across cohorts are presented.
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=54 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly (adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were screened and enrolled in Cohort A sub-study to receive Dostarlimab + Bevacizumab + Niraparib.
|
Cohort C (Niraparib OR Platinum-taxane)
n=119 Participants
Participants with ovarian cancer were screened and enrolled in Cohort C sub-study to receive either Niraparib OR Platinum-taxane.
|
|---|---|---|
|
Number of Participants Enrolled Across Cohorts
|
41 Participants
|
36 Participants
|
Adverse Events
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort C (Niraparib OR Platinum-taxane)
Serious events: 5 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=54 participants at risk
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly (adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were screened and enrolled in Cohort A sub-study to receive Dostarlimab + Bevacizumab + Niraparib.
|
Cohort C (Niraparib OR Platinum-taxane)
n=119 participants at risk
Participants with ovarian cancer were screened and enrolled in Cohort C sub-study to receive either Niraparib OR Platinum-taxane.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
2/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.00%
0/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.00%
0/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.00%
0/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.00%
0/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
General disorders
General physical health deterioration
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
General disorders
Pyrexia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
Other adverse events
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=54 participants at risk
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly (adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were screened and enrolled in Cohort A sub-study to receive Dostarlimab + Bevacizumab + Niraparib.
|
Cohort C (Niraparib OR Platinum-taxane)
n=119 participants at risk
Participants with ovarian cancer were screened and enrolled in Cohort C sub-study to receive either Niraparib OR Platinum-taxane.
|
|---|---|---|
|
Investigations
Amylase increased
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.00%
0/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.00%
0/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
1.7%
2/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
1.7%
2/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Investigations
Weight decreased
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
2.5%
3/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
1.7%
2/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
2/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
4.2%
5/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.00%
0/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.00%
0/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
4.2%
5/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
11.8%
14/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
5.0%
6/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
2.5%
3/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
2.5%
3/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
General disorders
Pyrexia
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
1.7%
2/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
General disorders
Fatigue
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
5.0%
6/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
General disorders
Asthenia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
2.5%
3/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
General disorders
Oedema peripheral
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
1.7%
2/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
General disorders
Chills
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
5.0%
6/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
2.5%
3/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
1.7%
2/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.00%
0/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Renal and urinary disorders
Dysuria
|
1.9%
1/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
10.9%
13/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
1.7%
2/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
5.9%
7/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
1.7%
2/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
2.5%
3/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
4.2%
5/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
2.5%
3/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Vascular disorders
Flushing
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
1.7%
2/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
1.7%
2/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/43 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Eye disorders
Vision blurred
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
2.5%
3/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
|
Vascular disorders
Hot flush
|
0.00%
0/54 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
0.84%
1/119 • Cohort A: Screening (-21 to 0 days) and Cohort C: Screening (-42 to 0 days)
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected for screened participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER