Trial Outcomes & Findings for Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer (NCT NCT01038778)
NCT ID: NCT01038778
Last Updated: 2025-09-15
Results Overview
Number of dose-limiting toxicities of entinostat when combined with aldesleukin within the Phase I MEASUREMENT OF EFFECT Patients underwent CT scans at week 11 (+/- 7 days) of each cycle during aldesleukin administration and then every 8-12 weeks (+/- 2 weeks). Response Evaluation Criteria in Solid Tumors (RECIST V.1.0)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
47 participants
Primary outcome timeframe
84 days
Results posted on
2025-09-15
Participant Flow
Participant milestones
| Measure |
Phase I Dose Level 1
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Phase I Dose Level 2
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Phase 2 Dose Level 2
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
8
|
36
|
|
Overall Study
COMPLETED
|
3
|
6
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
3
|
Reasons for withdrawal
| Measure |
Phase I Dose Level 1
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Phase I Dose Level 2
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Phase 2 Dose Level 2
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
3
|
Baseline Characteristics
Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=3 Participants
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Dose Level 2
n=44 Participants
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 14.73 • n=5 Participants
|
55.64 years
STANDARD_DEVIATION 8.35 • n=7 Participants
|
55.53 years
STANDARD_DEVIATION 8.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 84 daysPopulation: All treated and eligible Phase 1 patients
Number of dose-limiting toxicities of entinostat when combined with aldesleukin within the Phase I MEASUREMENT OF EFFECT Patients underwent CT scans at week 11 (+/- 7 days) of each cycle during aldesleukin administration and then every 8-12 weeks (+/- 2 weeks). Response Evaluation Criteria in Solid Tumors (RECIST V.1.0)
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Dose Level 2
n=8 Participants
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|
|
Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All Phase II treated and eligible patients
The proportion of patients who have a partial or complete response to treatment evaluated by RECIST V.1.0 criteria. MEASUREMENT OF EFFECT Patients underwent CT scans at week 11 (+/- 7 days) of each cycle during aldesleukin administration and then every 8-12 weeks (+/- 2 weeks). Response Evaluation Criteria in Solid Tumors (RECIST V.1.0)
Outcome measures
| Measure |
Dose Level 1
n=36 Participants
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Dose Level 2
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|
|
Overall Response Rate (Complete Plus Partial) (Phase II)
|
.39 Proportion of participants
Interval 0.26 to 0.54
|
—
|
SECONDARY outcome
Timeframe: 84 daysPopulation: All Phase I patients
Count of participants with grade 4 toxicity. The frequency and grade of toxicities will be tabulated for each dose level.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Dose Level 2
n=8 Participants
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|
|
Incidence of Toxicity (Phase I)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 12-months after the last subject enrollsPopulation: All Phase 2 patients. PFS only assessed for Phase 2.
The median progression-free survival (PFS) was estimated using standard Kaplan-Meier methods, where estimates of the median were obtained with 95% confidence intervals (CIs). PFS was defined as the time from the start of treatment to progression or death due to any cause or last follow-up, patients who did not progress or die were censored. MEASUREMENT OF EFFECT Patients underwent CT scans at week 11 (+/- 7 days) of each cycle during aldesleukin administration and then every 8-12 weeks (+/- 2 weeks). Response Evaluation Criteria in Solid Tumors (RECIST V.1.0)
Outcome measures
| Measure |
Dose Level 1
n=36 Participants
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Dose Level 2
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|
|
Progression-free Survival
|
14.0 months
Interval 6.0 to
Upper limit not reached
|
—
|
SECONDARY outcome
Timeframe: up to 12-months after the last subject enrollsPopulation: All Phase 2 patients. Overall Survival only assessed for Phase 2.
The 3-year overall survival (OS) rate was estimated using standard Kaplan-Meier methods, where estimates of the median were obtained with 95% confidence intervals (CIs). OS was defined as the time from the start of treatment to death due to any cause or last follow-up, patients who did not die were censored.
Outcome measures
| Measure |
Dose Level 1
n=36 Participants
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Dose Level 2
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|
|
Overall Survival
|
82.1 percentage of participants
Interval 62.0 to 93.0
|
—
|
SECONDARY outcome
Timeframe: up to 12-months after the last subject enrollsPopulation: All Phase 2 patients.TTP only assessed for Phase 2.
The median time to tumor progression (TTP) was estimated using standard Kaplan-Meier methods, where estimates of the median were obtained with 95% confidence intervals (CIs). TTP was defined as the time from the start of treatment to progression or last follow-up. Patients that did not progress were censored.
Outcome measures
| Measure |
Dose Level 1
n=36 Participants
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Dose Level 2
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|
|
Time-to-tumor Progression
|
14 months
Interval 6.0 to
Upper limit not reached
|
—
|
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: All Phase 2 patients. Toxicities only assessed for Phase 2.
The number of participants with serious adverse events.
Outcome measures
| Measure |
Dose Level 1
n=36 Participants
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Dose Level 2
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|
|
Incidence of Toxicities
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to approximately 4 weeks post-treatment, up to 1 yearPopulation: All treated and evaluable patients
Mean percent change from baseline of T lymphocytes.
Outcome measures
| Measure |
Dose Level 1
n=1 Participants
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Dose Level 2
n=35 Participants
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|
|
Changes in the Level of Specific T Lymphocytes
|
26.3 percentage of cells count
Standard Deviation NA
only 1 obsevation
|
10.5 percentage of cells count
Standard Deviation 70.8
|
SECONDARY outcome
Timeframe: Baseline to approximately 5 weeks post-treatmentPopulation: Data for this outcome was not collected. The investigator transferred from Hopkins to Roswell Park and the data for this outcome was not collected.
For binary predictors, the sensitivity and specificity with 95% confidence intervals will be reported. T tests will be used to compare the mean change between responders and non-responders. If there are sufficient numbers of responders, partial responders and non-responders an ANOVA will be used to compare changes in these three groups. If complete data are obtained for CD4+CD25\^hi T cells at multiple time points post treatment, repeated measures ANOVA will be performed to evaluate data for trends over time.
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 3 deaths
Dose Level 2
Serious events: 9 serious events
Other events: 35 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Dose Level 2
n=44 participants at risk
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|
|
Cardiac disorders
Pericarditis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Chest pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Death
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Fatigue
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
White blood cell count
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Dose Level 1 Entinostat (3 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
Dose Level 2
n=44 participants at risk
Dose Level 2 Entinostat (5 mg, every 2 weeks, PO) Aldesleukin (600,000 IU/kg, every 8hrs, IV)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
61.4%
27/44 • Number of events 117 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
13.6%
6/44 • Number of events 9 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
27.3%
12/44 • Number of events 18 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
20.5%
9/44 • Number of events 22 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Cardiac disorders
Ventricular arrhythmia
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
0.00%
0/44 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 4 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
11.4%
5/44 • Number of events 5 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
31.8%
14/44 • Number of events 24 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
20.5%
9/44 • Number of events 13 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
11.4%
5/44 • Number of events 6 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
68.2%
30/44 • Number of events 83 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
52.3%
23/44 • Number of events 43 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 4 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Chest pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
47.7%
21/44 • Number of events 51 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 5 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
72.7%
32/44 • Number of events 97 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Malaise
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Mucosal inflammation
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Oedema
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
18.2%
8/44 • Number of events 15 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
20.5%
9/44 • Number of events 17 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Polyp
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 4 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
52.3%
23/44 • Number of events 83 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
General disorders
Xerosis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
13.6%
6/44 • Number of events 12 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 4 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Adjusted calcium
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Alanine aminotransferase
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
0.00%
0/44 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Alanine aminotransferase decreased
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
0.00%
0/44 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
13.6%
6/44 • Number of events 7 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Blood albumin
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 5 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Blood bilirubin
|
33.3%
1/3 • Number of events 4 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
45.5%
20/44 • Number of events 62 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Blood creatinine
|
33.3%
1/3 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 4 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Blood lactate dehydrogenase decreased
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
0.00%
0/44 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Blood thyroid stimulating hormone increased
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
0.00%
0/44 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Haemoglobin
|
33.3%
1/3 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
0.00%
0/44 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Haemoglobin decreased
|
33.3%
1/3 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
0.00%
0/44 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
13.6%
6/44 • Number of events 7 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Lymphocyte count
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
40.9%
18/44 • Number of events 82 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Neutrophil count
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
18.2%
8/44 • Number of events 21 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Troponin increased
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
0.00%
0/44 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
Weight increased
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
20.5%
9/44 • Number of events 25 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Investigations
White blood cell count
|
33.3%
1/3 • Number of events 5 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
43.2%
19/44 • Number of events 58 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
52.3%
23/44 • Number of events 46 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
11.4%
5/44 • Number of events 5 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
56.8%
25/44 • Number of events 61 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
25.0%
11/44 • Number of events 15 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
15.9%
7/44 • Number of events 20 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
15.9%
7/44 • Number of events 8 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Number of events 5 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
63.6%
28/44 • Number of events 126 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Number of events 8 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
61.4%
27/44 • Number of events 154 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
33.3%
1/3 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
25.0%
11/44 • Number of events 18 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
27.3%
12/44 • Number of events 34 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Number of events 4 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
52.3%
23/44 • Number of events 73 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
61.4%
27/44 • Number of events 123 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
11.4%
5/44 • Number of events 11 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
15.9%
7/44 • Number of events 8 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 4 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 4 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
25.0%
11/44 • Number of events 15 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
11.4%
5/44 • Number of events 6 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
22.7%
10/44 • Number of events 16 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
29.5%
13/44 • Number of events 32 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 4 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
13.6%
6/44 • Number of events 8 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
34.1%
15/44 • Number of events 23 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
20.5%
9/44 • Number of events 14 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 4 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
15.9%
7/44 • Number of events 12 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
13.6%
6/44 • Number of events 15 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
13.6%
6/44 • Number of events 8 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
11.4%
5/44 • Number of events 7 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
27.3%
12/44 • Number of events 21 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
52.3%
23/44 • Number of events 53 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
9.1%
4/44 • Number of events 6 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
15.9%
7/44 • Number of events 10 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
29.5%
13/44 • Number of events 20 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
9.1%
4/44 • Number of events 5 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
47.7%
21/44 • Number of events 32 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
11.4%
5/44 • Number of events 7 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
4.5%
2/44 • Number of events 2 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
6.8%
3/44 • Number of events 5 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
2.3%
1/44 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
9.1%
4/44 • Number of events 5 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
22.7%
10/44 • Number of events 22 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
11.4%
5/44 • Number of events 7 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 3 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
59.1%
26/44 • Number of events 73 • From the start date of intervention until 30 days after the last intervention, up to 1 year
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 7168451300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60