Trial Outcomes & Findings for A Two Arm Trial of Axitinib and Carboplatin/Paclitaxel in Melanoma (NCT NCT01174238)
NCT ID: NCT01174238
Last Updated: 2018-06-08
Results Overview
ORR is defined as the percentage of patients with tumor size reduction, i.e. the sum of partial responses plus complete responses. Radiographic response was evaluated using RECIST criteria during every 21-day cycle of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Monthly during study treatment, up to 12 months
Results posted on
2018-06-08
Participant Flow
40 patients were consented; two participants were lost to follow-up prior to treatment and hence were not included in any analyses
Participant milestones
| Measure |
Axitinib + Carboplatin/Paclitaxel
Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy
Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
Participants That Underwent FLT-PET Scan
|
6
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Axitinib + Carboplatin/Paclitaxel
Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy
Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
A Two Arm Trial of Axitinib and Carboplatin/Paclitaxel in Melanoma
Baseline characteristics by cohort
| Measure |
Axitinib+Carboplatin/Paclitaxel, Including FLT-PET Patients
n=38 Participants
Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy
Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.
6 patients in this group received drug treatment and in addition underwent FLT-PET during first treatment cycle.
|
|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 10.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Monthly during study treatment, up to 12 monthsPopulation: Two patients discontinued treatment due to toxicity within the first 3 weeks, prior to the first infusion of paclitaxel/carboplatin, and were considered to be evaluable for toxicity but not for response.
ORR is defined as the percentage of patients with tumor size reduction, i.e. the sum of partial responses plus complete responses. Radiographic response was evaluated using RECIST criteria during every 21-day cycle of treatment.
Outcome measures
| Measure |
Axitinib + Carboplatin/Paclitaxel
n=36 Participants
All enrolled patients received the same treatment with study drugs axitinib, carboplatin, and paclitaxel and had tumor imaging assessments: PET-CT, CT Scan, and/or MRI. 6 of 38 patients were selected to undergo FLT-PET scans.
1 treatment cycle: 21 days
* dual therapy: 5mg Axitinib on days 1-14, twice a day (BID)
* monotherapy: if patient completes ≥ 6 cycles, 5mg Axitinib every day, once a day (QD)
Carboplatin: Day 1 of each treatment cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients in dual therapy phase.
|
|---|---|
|
Objective Response Rate (ORR)
|
22 percentage of patients
|
SECONDARY outcome
Timeframe: Days 1, 14, 17, and 20 of cycle 1Optimal interval between the end of axitinib therapy and initiation of chemotherapy, as determined using FLT PET as a Radiological Biomarker information of Resumption of DNA Synthesis Following Axitinib Therapy.
Outcome measures
| Measure |
Axitinib + Carboplatin/Paclitaxel
n=5 Participants
All enrolled patients received the same treatment with study drugs axitinib, carboplatin, and paclitaxel and had tumor imaging assessments: PET-CT, CT Scan, and/or MRI. 6 of 38 patients were selected to undergo FLT-PET scans.
1 treatment cycle: 21 days
* dual therapy: 5mg Axitinib on days 1-14, twice a day (BID)
* monotherapy: if patient completes ≥ 6 cycles, 5mg Axitinib every day, once a day (QD)
Carboplatin: Day 1 of each treatment cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients in dual therapy phase.
|
|---|---|
|
Optimal Interval Between the End of Axitinib Therapy and Initiation of Chemotherapy
|
7 days
|
SECONDARY outcome
Timeframe: Baseline until death or up to 24 monthsOverall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact.
Outcome measures
| Measure |
Axitinib + Carboplatin/Paclitaxel
n=36 Participants
All enrolled patients received the same treatment with study drugs axitinib, carboplatin, and paclitaxel and had tumor imaging assessments: PET-CT, CT Scan, and/or MRI. 6 of 38 patients were selected to undergo FLT-PET scans.
1 treatment cycle: 21 days
* dual therapy: 5mg Axitinib on days 1-14, twice a day (BID)
* monotherapy: if patient completes ≥ 6 cycles, 5mg Axitinib every day, once a day (QD)
Carboplatin: Day 1 of each treatment cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients in dual therapy phase.
|
|---|---|
|
Overall Survival (OS)
|
14.0 months
Interval 10.0 to 17.9
|
SECONDARY outcome
Timeframe: within 7 days of odd cycles after cycle 1 for the duration of treatment, up to 12 cyclesOutcome measures
| Measure |
Axitinib + Carboplatin/Paclitaxel
n=36 Participants
All enrolled patients received the same treatment with study drugs axitinib, carboplatin, and paclitaxel and had tumor imaging assessments: PET-CT, CT Scan, and/or MRI. 6 of 38 patients were selected to undergo FLT-PET scans.
1 treatment cycle: 21 days
* dual therapy: 5mg Axitinib on days 1-14, twice a day (BID)
* monotherapy: if patient completes ≥ 6 cycles, 5mg Axitinib every day, once a day (QD)
Carboplatin: Day 1 of each treatment cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients in dual therapy phase.
|
|---|---|
|
Time to Progression (TTP)
|
8.7 months
Interval 5.5 to 12.0
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 20Population: Five patients completed both pre- and post-treatment (18)F-FLT PET scans; one patient had minimal (18)F-FLT uptake at baseline
(18)F-FLT uptake values following a 7-day treatment holiday compared to the lower of Baseline or Day 14 value.
Outcome measures
| Measure |
Axitinib + Carboplatin/Paclitaxel
n=4 Participants
All enrolled patients received the same treatment with study drugs axitinib, carboplatin, and paclitaxel and had tumor imaging assessments: PET-CT, CT Scan, and/or MRI. 6 of 38 patients were selected to undergo FLT-PET scans.
1 treatment cycle: 21 days
* dual therapy: 5mg Axitinib on days 1-14, twice a day (BID)
* monotherapy: if patient completes ≥ 6 cycles, 5mg Axitinib every day, once a day (QD)
Carboplatin: Day 1 of each treatment cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients in dual therapy phase.
|
|---|---|
|
Increase From Nadir in the Sum of Maximum (18)F-FLT Uptake Values After Treatment Holiday
|
4 participants
|
Adverse Events
Axitinib + Carboplatin/Paclitaxel
Serious events: 12 serious events
Other events: 32 other events
Deaths: 0 deaths
Axitinib + Carboplatin/Paclitaxel and With FLT-PET Scans
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Axitinib + Carboplatin/Paclitaxel
n=32 participants at risk
Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy
Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.
|
Axitinib + Carboplatin/Paclitaxel and With FLT-PET Scans
n=6 participants at risk
Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy
Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.
FLT-PET during first treatment cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Infections and infestations
Other
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Surgical and medical procedures
Appendicitis
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Metabolism and nutrition disorders
anorexia
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
confusion
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Renal and urinary disorders
acute kidney disease
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Blood and lymphatic system disorders
anemaia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Vascular disorders
thromboembolic event
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Cardiac disorders
heart failure
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Psychiatric disorders
other
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Vascular disorders
transient ischemic attack
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
ataxia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Blood and lymphatic system disorders
dizziness
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
vomiting
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
abdominal pain
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Infections and infestations
urinary tract infection
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
failure to thrive
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Infections and infestations
fever
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Cardiac disorders
chest pain
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Cardiac disorders
supraventricular tachycardia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
Other adverse events
| Measure |
Axitinib + Carboplatin/Paclitaxel
n=32 participants at risk
Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy
Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.
|
Axitinib + Carboplatin/Paclitaxel and With FLT-PET Scans
n=6 participants at risk
Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy
Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase
Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.
FLT-PET during first treatment cycle.
|
|---|---|---|
|
Nervous system disorders
Peripheral sensory neuropathy
|
62.5%
20/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
83.3%
5/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Dizziness
|
37.5%
12/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
66.7%
4/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Headache
|
28.1%
9/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
50.0%
3/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Dysgeusia
|
21.9%
7/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Paresthesia
|
12.5%
4/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Memory impairment
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Syncope
|
9.4%
3/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Ataxia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Dysarthria
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
46.9%
15/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
50.0%
3/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
15.6%
5/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Vascular disorders
Hypertension
|
43.8%
14/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
66.7%
4/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Vascular disorders
Hypotension
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Transient ischemic attacks
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Concentration impairment
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Depressed level of consciousness
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Presyncope
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Seizure
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Vascular disorders
Flushing
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Spasticity
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Nervous system disorders
Tremor
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
53.1%
17/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
83.3%
5/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Vascular disorders
Hot flashes
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Vascular disorders
Thromboembolic event
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
18.8%
6/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
50.0%
3/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Investigations
Neutrophil count decreased
|
31.2%
10/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
18.8%
6/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
4/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
34.4%
11/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
66.7%
4/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
34.4%
11/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.9%
7/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
50.0%
3/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.9%
7/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.9%
7/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
15.6%
5/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.5%
4/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
12.5%
4/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Investigations
Platelet count decreased
|
31.2%
10/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
Fatigue
|
84.4%
27/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
83.3%
5/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
Chills
|
21.9%
7/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
Gait disturbance
|
12.5%
4/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
Edema limbs
|
15.6%
5/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
Non-cardiac chest pain
|
15.6%
5/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
Pain
|
15.6%
5/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
Fever
|
9.4%
3/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
Infusion related reaction
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
Flu like symptoms
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
Infusion site extravasation
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
General disorders
Malaise
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
65.6%
21/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
66.7%
4/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
62.5%
20/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
50.0%
3/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Constipation
|
56.2%
18/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
66.7%
4/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
40.6%
13/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
50.0%
3/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
28.1%
9/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
4/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.5%
4/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Bloating
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Flatulence
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Stomach pain
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Gingival pain
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Rectal pain
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
34.4%
11/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
83.3%
5/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
43.8%
14/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
28.1%
9/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.9%
7/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
50.0%
3/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
25.0%
8/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
18.8%
6/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.4%
3/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.4%
3/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
12.5%
4/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Investigations
Weight loss
|
18.8%
6/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Investigations
Investigations - Other, specify
|
9.4%
3/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Investigations
Ejection fraction decreased
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Investigations
White blood cell decreased
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Psychiatric disorders
Insomnia
|
21.9%
7/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
50.0%
3/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Psychiatric disorders
Confusion
|
15.6%
5/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Psychiatric disorders
Depression
|
15.6%
5/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Psychiatric disorders
Agitation
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Eye disorders
Blurred vision
|
31.2%
10/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Eye disorders
Eye disorders - Other, specify
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Eye disorders
Eye pain
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Eye disorders
Photophobia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
8/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
4/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Infections and infestations
Appendicitis
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Infections and infestations
Skin infection
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Infections and infestations
Otitis media
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Infections and infestations
Rash pustular
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Infections and infestations
Urinary tract infection
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Endocrine disorders
Hypothyroidism
|
21.9%
7/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Endocrine disorders
Hyperthyroidism
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
4/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
33.3%
2/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
50.0%
3/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Renal and urinary disorders
Urinary urgency
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Renal and urinary disorders
Urinary frequency
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
9.4%
3/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Cardiac disorders
Chest pain - cardiac
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Cardiac disorders
Palpitations
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Cardiac disorders
Heart failure
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Cardiac disorders
Sinus tachycardia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Ear and labyrinth disorders
External ear inflammation
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Ear and labyrinth disorders
Vestibular disorder
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
6.2%
2/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
3.1%
1/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
0.00%
0/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/32 • Patients were assessed during study treatment for adverse events up to 12 months
|
16.7%
1/6 • Patients were assessed during study treatment for adverse events up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place