Trial Outcomes & Findings for Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer (NCT NCT05112536)
NCT ID: NCT05112536
Last Updated: 2024-03-12
Results Overview
Evaluated 7 days after a single-dose of trilaciclib, measured by the change in CD8+ T cells/regulatory T cells (Treg) ratio in tumor tissue; post-trilaciclib ratio minus pre-trilaciclib ratio. Research shows a correlation between immune cells, (tumor-infiltrating lymphocytes - TILs), and favorable outcomes. Both the presence of effector CD8+ T cells and the ratio of effector CD8+ T cells to immune-suppressive regulatory T cells (Treg) correlate with improved outcome and long-term survival in solid cancers. Therefore, the higher the ratio of CD8+ T cells/Tregs, the better the predicted outcome for a patient. This outcome measure is completed by looking at tumor tissue under a microscope.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Up to 8 days after lead-in trilaciclib dose
Results posted on
2024-03-12
Participant Flow
Participants were recruited based on physician referral at 7 clinical locations, including academic, community, and hospital network locations. Recruitment occurred between November 2021 and August 2022. The first participant was enrolled on March 3rd, 2022. The last participant was enrolled on August 2nd, 2022.
24 participants were enrolled. As an open-label study, all participants received trilaciclib during the monotherapy, lead-in phase, followed by trilaciclib plus doxorubicin/cyclophosphamide and paclitaxel (AC/T). Additions of pembrolizumab and/or carboplatin were at physician discretion.
Participant milestones
| Measure |
Trilaciclib Plus Chemotherapy
All subjects received trilaciclib lead-in (240mg/m2) single dose monotherapy, followed by trilaciclib plus anthracycline/cyclophosphamide (Trilaciclib (240mg/m2) + doxorubicin (60 mg/m2) + cyclophosphamide (600 mg/m2) + pembrolizumab (per Investigator discretion; 400mg)), then trilaciclib plus taxane chemotherapy (Trilaciclib (240mg/m2) + paclitaxel (80 mg/m2) + carboplatin (per Investigator discretion; AUC 1.5) + pembrolizumab (per Investigator discretion; 400mg).
Trilaciclib: Trilaciclib is administered IV as monotherapy during the lead-in phase and administered prior to chemotherapy on each day chemotherapy is administered during the treatment phase.
Cylophosphamide: Cyclophosphamide administered IV every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
Doxorubicin: Doxorubicin administered as an IV bolus every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
Paclitaxel: Paclitaxel administered weekly for the last 12 cycles (cycles 5-16), each cycle 1 week in length.
Carboplatin (Investigator discretion): Carboplatin, if given, is administered IV weekly at the start of paclitaxel administration, for the last 12 cycles (cycles 5-16).
Pembrolizumab (Investigator discretion): Pembrolizumab, if given, is administered IV every 6 weeks throughout the treatment phase (cycles 1, 4, 9, 15).
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Trilaciclib Plus Chemotherapy
n=24 Participants
All subjects received trilaciclib lead-in (240mg/m2) single dose monotherapy, followed by trilaciclib plus anthracycline/cyclophosphamide (Trilaciclib (240mg/m2) + doxorubicin (60 mg/m2) + cyclophosphamide (600 mg/m2) + pembrolizumab (per Investigator discretion; 400mg)), then trilaciclib plus taxane chemotherapy (Trilaciclib (240mg/m2) + paclitaxel (80 mg/m2) + carboplatin (per Investigator discretion; AUC 1.5) + pembrolizumab (per Investigator discretion; 400mg).
Trilaciclib: Trilaciclib is administered IV as monotherapy during the lead-in phase and administered prior to chemotherapy on each day chemotherapy is administered during the treatment phase.
Cylophosphamide: Cyclophosphamide administered IV every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
Doxorubicin: Doxorubicin administered as an IV bolus every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
Paclitaxel: Paclitaxel administered weekly for the last 12 cycles (cycles 5-16), each cycle 1 week in length.
Carboplatin (Investigator discretion): Carboplatin, if given, is administered IV weekly at the start of paclitaxel administration, for the last 12 cycles (cycles 5-16).
Pembrolizumab (Investigator discretion): Pembrolizumab, if given, is administered IV every 6 weeks throughout the treatment phase (cycles 1, 4, 9, 15).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Age, Continuous
|
57.0 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=93 Participants
|
|
Body Mass Index (BMI)
|
29.88 kg/m2
STANDARD_DEVIATION 9.219 • n=93 Participants
|
|
Stage at diagnosis
Stage I
|
2 Participants
n=93 Participants
|
|
Stage at diagnosis
Stage II
|
19 Participants
n=93 Participants
|
|
Stage at diagnosis
Stage III
|
3 Participants
n=93 Participants
|
|
Histologic Grade
Grade 1
|
1 Participants
n=93 Participants
|
|
Histologic Grade
Grade 2
|
3 Participants
n=93 Participants
|
|
Histologic Grade
Grade 3
|
20 Participants
n=93 Participants
|
|
Histopathological type at diagnosis
Ductal
|
20 Participants
n=93 Participants
|
|
Histopathological type at diagnosis
Lobular
|
1 Participants
n=93 Participants
|
|
Histopathological type at diagnosis
Other
|
3 Participants
n=93 Participants
|
|
BRCA Mutation Status
Negative
|
10 Participants
n=93 Participants
|
|
BRCA Mutation Status
BRCA 1
|
1 Participants
n=93 Participants
|
|
BRCA Mutation Status
BRCA 2
|
0 Participants
n=93 Participants
|
|
BRCA Mutation Status
BRCA 1/2
|
1 Participants
n=93 Participants
|
|
BRCA Mutation Status
Not done/Other
|
12 Participants
n=93 Participants
|
|
PD-L1 status
Positive
|
1 Participants
n=93 Participants
|
|
PD-L1 status
Negative
|
2 Participants
n=93 Participants
|
|
PD-L1 status
Not done/Unknown
|
21 Participants
n=93 Participants
|
|
Easter Cooperative Oncology Group (ECOG) Score
0
|
22 Participants
n=93 Participants
|
|
Easter Cooperative Oncology Group (ECOG) Score
1
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 8 days after lead-in trilaciclib dosePopulation: Full Analysis Set 1 (FAS1), defined as all enrolled participants who received trilaciclib during the Trilaciclib Lead-in Phase, for whom pre-trilaciclib and post-trilaciclib monotherapy biopsies were available for analysis.
Evaluated 7 days after a single-dose of trilaciclib, measured by the change in CD8+ T cells/regulatory T cells (Treg) ratio in tumor tissue; post-trilaciclib ratio minus pre-trilaciclib ratio. Research shows a correlation between immune cells, (tumor-infiltrating lymphocytes - TILs), and favorable outcomes. Both the presence of effector CD8+ T cells and the ratio of effector CD8+ T cells to immune-suppressive regulatory T cells (Treg) correlate with improved outcome and long-term survival in solid cancers. Therefore, the higher the ratio of CD8+ T cells/Tregs, the better the predicted outcome for a patient. This outcome measure is completed by looking at tumor tissue under a microscope.
Outcome measures
| Measure |
Trilaciclib Plus Chemotherapy
n=23 Participants
Trilaciclib lead-in, followed by trilaciclib plus anthracycline/cyclophosphamide, then trilaciclib plus taxane chemotherapy:
* Lead-in trilaciclib (240mg/m2) single dose monotherapy
* Trilaciclib (240mg/m2) + doxorubicin (60 mg/m2) + cyclophosphamide (600 mg/m2) + pembrolizumab (per Investigator discretion; 400mg)
* Trilaciclib (240mg/m2) + paclitaxel (80 mg/m2) + carboplatin (per Investigator discretion; AUC 1.5) + pembrolizumab (per Investigator discretion; 400mg)
Trilaciclib: Trilaciclib is administered IV as monotherapy during the lead-in phase and administered prior to chemotherapy on each day chemotherapy is administered during the treatment phase.
Cylophosphamide: Cyclophosphamide administered IV every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
Doxorubicin: Doxorubicin administered as an IV bolus every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
Paclitaxel: Paclitaxel administered weekly for the last 12 cycles (cycles 5-16), each cycle 1 week in length.
Carboplatin (Investigator discretion): Carboplatin, if given, is administered IV weekly at the start of paclitaxel administration, for the last 12 cycles (cycles 5-16).
Pembrolizumab (Investigator discretion): Pembrolizumab, if given, is administered IV every 6 weeks throughout the treatment phase (cycles 1, 4, 9, 15).
|
|---|---|
|
Immune-based Mechanism of Action
|
0.3 CD8+/Tregs ratio
Interval -0.5 to 2.7
|
SECONDARY outcome
Timeframe: Up to 26 weeksPopulation: Full Analysis Set (FAS), enrolled participants who received at least one dose of any study drug during the treatment period, where treatment period consists of Trilaciclib Lead-in Phase and the Treatment Phase.
Rate of pCR using the definition of ypT0/Tis ypN0 (i.e., no invasive residual tumor in breast or nodes; noninvasive breast residuals allowed) as assessed by the local pathologist.
Outcome measures
| Measure |
Trilaciclib Plus Chemotherapy
n=24 Participants
Trilaciclib lead-in, followed by trilaciclib plus anthracycline/cyclophosphamide, then trilaciclib plus taxane chemotherapy:
* Lead-in trilaciclib (240mg/m2) single dose monotherapy
* Trilaciclib (240mg/m2) + doxorubicin (60 mg/m2) + cyclophosphamide (600 mg/m2) + pembrolizumab (per Investigator discretion; 400mg)
* Trilaciclib (240mg/m2) + paclitaxel (80 mg/m2) + carboplatin (per Investigator discretion; AUC 1.5) + pembrolizumab (per Investigator discretion; 400mg)
Trilaciclib: Trilaciclib is administered IV as monotherapy during the lead-in phase and administered prior to chemotherapy on each day chemotherapy is administered during the treatment phase.
Cylophosphamide: Cyclophosphamide administered IV every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
Doxorubicin: Doxorubicin administered as an IV bolus every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
Paclitaxel: Paclitaxel administered weekly for the last 12 cycles (cycles 5-16), each cycle 1 week in length.
Carboplatin (Investigator discretion): Carboplatin, if given, is administered IV weekly at the start of paclitaxel administration, for the last 12 cycles (cycles 5-16).
Pembrolizumab (Investigator discretion): Pembrolizumab, if given, is administered IV every 6 weeks throughout the treatment phase (cycles 1, 4, 9, 15).
|
|---|---|
|
Pathologic Complete Response (pCR) Rate
Achieved pCR
|
10 Participants
|
|
Pathologic Complete Response (pCR) Rate
Did not achieve pCR
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 28 weeksPopulation: Full Analysis Set 2 (FAS2), included enrolled patients who had received at least one dose of a study drug during the Treatment Phase of the study.
Safety/tolerability as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Outcome measures
| Measure |
Trilaciclib Plus Chemotherapy
n=24 Participants
Trilaciclib lead-in, followed by trilaciclib plus anthracycline/cyclophosphamide, then trilaciclib plus taxane chemotherapy:
* Lead-in trilaciclib (240mg/m2) single dose monotherapy
* Trilaciclib (240mg/m2) + doxorubicin (60 mg/m2) + cyclophosphamide (600 mg/m2) + pembrolizumab (per Investigator discretion; 400mg)
* Trilaciclib (240mg/m2) + paclitaxel (80 mg/m2) + carboplatin (per Investigator discretion; AUC 1.5) + pembrolizumab (per Investigator discretion; 400mg)
Trilaciclib: Trilaciclib is administered IV as monotherapy during the lead-in phase and administered prior to chemotherapy on each day chemotherapy is administered during the treatment phase.
Cylophosphamide: Cyclophosphamide administered IV every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
Doxorubicin: Doxorubicin administered as an IV bolus every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.
Paclitaxel: Paclitaxel administered weekly for the last 12 cycles (cycles 5-16), each cycle 1 week in length.
Carboplatin (Investigator discretion): Carboplatin, if given, is administered IV weekly at the start of paclitaxel administration, for the last 12 cycles (cycles 5-16).
Pembrolizumab (Investigator discretion): Pembrolizumab, if given, is administered IV every 6 weeks throughout the treatment phase (cycles 1, 4, 9, 15).
|
|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Adverse Events CTCAE grade >/= 3
|
15 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Adverse Events CTCAE grade >/= 4
|
5 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Study drug related adverse event
|
24 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Study drug related serious adverse event
|
2 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Trilaciclib-related adverse event leading to discontinuation
|
0 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Adverse event leading to death
|
0 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Trilaciclib adverse events of special interest (AESI)
|
10 Participants
|
Adverse Events
Trilaciclib Plus Chemotherapy
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trilaciclib Plus Chemotherapy
n=24 participants at risk
All subjects received trilaciclib lead-in (240mg/m2) single dose monotherapy, followed by trilaciclib plus anthracycline/cyclophosphamide (Trilaciclib (240mg/m2) + doxorubicin (60 mg/m2) + cyclophosphamide (600 mg/m2) + pembrolizumab (per Investigator discretion; 400mg)), then trilaciclib plus taxane chemotherapy (Trilaciclib (240mg/m2) + paclitaxel (80 mg/m2) + carboplatin (per Investigator discretion; AUC 1.5) + pembrolizumab (per Investigator discretion; 400mg).
This trial investigated the mechanism of action of trilaciclib, and not safety profile comparison between trilaciclib treated patients receiving or not receiving pembrolizumab, nor comparison of the safety profile between trilaciclib treated subjects receiving or not receiving carboplatin. This was a single-arm study; only 1 treatment arm/group was prospectively defined. Therefore safety was reported in accordance to the study design (i.e., a single arm/group). Additionally, 21 of 24 subjects enrolled were treated with pembrolizumab and 21 of 24 patients enrolled were treated with carboplatin. Thus, the safety reporting as a single group is representative of the vast majority of participants (21/24 (87.5%)).
|
|---|---|
|
Infections and infestations
Abscess limb
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
COVID-19
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Herpes simplex encephalitis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Pneumonia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Sepsis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Urosepsis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Vascular disorders
Deep vein thrombosis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Vascular disorders
Orthostatic hypotension
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Colitis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Physical deconditioning
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
Other adverse events
| Measure |
Trilaciclib Plus Chemotherapy
n=24 participants at risk
All subjects received trilaciclib lead-in (240mg/m2) single dose monotherapy, followed by trilaciclib plus anthracycline/cyclophosphamide (Trilaciclib (240mg/m2) + doxorubicin (60 mg/m2) + cyclophosphamide (600 mg/m2) + pembrolizumab (per Investigator discretion; 400mg)), then trilaciclib plus taxane chemotherapy (Trilaciclib (240mg/m2) + paclitaxel (80 mg/m2) + carboplatin (per Investigator discretion; AUC 1.5) + pembrolizumab (per Investigator discretion; 400mg).
This trial investigated the mechanism of action of trilaciclib, and not safety profile comparison between trilaciclib treated patients receiving or not receiving pembrolizumab, nor comparison of the safety profile between trilaciclib treated subjects receiving or not receiving carboplatin. This was a single-arm study; only 1 treatment arm/group was prospectively defined. Therefore safety was reported in accordance to the study design (i.e., a single arm/group). Additionally, 21 of 24 subjects enrolled were treated with pembrolizumab and 21 of 24 patients enrolled were treated with carboplatin. Thus, the safety reporting as a single group is representative of the vast majority of participants (21/24 (87.5%)).
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
83.3%
20/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Constipation
|
45.8%
11/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Diarrhoea
|
45.8%
11/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Stomatitis
|
41.7%
10/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
6/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
4/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
4/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Vomitting
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Aphthous ulcer
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Gastrointestinal disorders
Toothache
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Fatigue
|
87.5%
21/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Oedema peripheral
|
16.7%
4/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Pyrexia
|
16.7%
4/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Catheter site pain
|
12.5%
3/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Oedema
|
12.5%
3/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Pain
|
12.5%
3/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Auxillary pain
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Mucosal inflammation
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Catheter site erythema
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Catheter site pruritis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Chest discomfort
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Chills
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Injection site pain
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Peripheral swelling
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
General disorders
Thirst
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
70.8%
17/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
25.0%
6/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.8%
5/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
16.7%
4/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
16.7%
4/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Onychclasis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Headache
|
50.0%
12/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Neuropathy peripheral
|
45.8%
11/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Dysgeusia
|
33.3%
8/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Dizziness
|
25.0%
6/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Paraesthesia
|
12.5%
3/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Restless leg syndrome
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Ageusia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Amnesia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Hypoaesthesia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Ophthalmic migraine
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Parosmia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Presyncope
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Nervous system disorders
Taste disorder
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Blood and lymphatic system disorders
Anaemia
|
41.7%
10/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Blood and lymphatic system disorders
Neutropenia
|
37.5%
9/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
3/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Oral herpes
|
20.8%
5/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Urinary tract infection
|
16.7%
4/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Eye infection
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Sinusitis
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Tooth infection
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Vaginal infection
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Abscess limb
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
COVID-19
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Candida infection
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Conjunctivitis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Furuncle
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Groin infection
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Herpes zoster
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Hordeolum
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Infection
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Nail infection
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Perineal abscess
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Infections and infestations
Sepsis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
8/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.8%
5/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.8%
5/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
4/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
4/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
3/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
6/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
6/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
4/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Investigations
Neutrophil count decreased
|
37.5%
9/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Investigations
Platelet count decreased
|
20.8%
5/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
3/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Investigations
Aspartate aminotransferase increase
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Investigations
White blood cell count decreased
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Investigations
Blood creatinine increased
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Investigations
Blood urea increased
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Investigations
Lymphocyte count decreased
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Investigations
Protein total decreased
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Investigations
Red blood cell count decreased
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Investigations
Weight decreased
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Psychiatric disorders
Insomnia
|
33.3%
8/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Psychiatric disorders
Anxiety
|
25.0%
6/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Psychiatric disorders
Adjustment disorder
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Psychiatric disorders
Irritabiliy
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Psychiatric disorders
Restlessness
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
29.2%
7/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
3/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Vascular disorders
Hot flush
|
16.7%
4/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Vascular disorders
Deep vein thrombosis
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Vascular disorders
Flushing
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Vascular disorders
Hypertension
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Vascular disorders
Embolism
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Vascular disorders
Lymphocele
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Vascular disorders
Orthostatic hypotension
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Injury, poisoning and procedural complications
Procedural pain
|
20.8%
5/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Eye disorders
Lacrimation increased
|
12.5%
3/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Eye disorders
Vision blurred
|
12.5%
3/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Eye disorders
Dry eye
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Eye disorders
Cataract
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Eye disorders
Eye ulcer
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Reproductive system and breast disorders
Breast pain
|
12.5%
3/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Renal and urinary disorders
Dysuria
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Renal and urinary disorders
Glycosuria
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Renal and urinary disorders
Haematuria
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Renal and urinary disorders
Micturition urgency
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Renal and urinary disorders
Pollakiuria
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Immune system disorders
Hypersensitivity
|
8.3%
2/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Immune system disorders
Seasonal allergy
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Cardiac disorders
Cardiac failure congestive
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Cardiac disorders
Tachycardia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Ear and labyrinth disorders
Ear pain
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Endocrine disorders
Hypothyroidism
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
4.2%
1/24 • 28 weeks
The statistical analysis plan pre-specified the collection of adverse events for all participants as a single arm/group irrespective of intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator agrees to submit any disclosure to Sponsor for review at least thirty (30) days prior to submission. Within sixty (60) days of its receipt, Sponsor can provide feedback on any disclosure Sponsor may require Investigator to remove, Confidential Information (other than study data), and/or to delay the proposed publication or presentation for an additional sixty (60) days to enable Sponsor to seek patent protection for inventions.
- Publication restrictions are in place
Restriction type: OTHER