Trial Outcomes & Findings for Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer (NCT NCT01367002)
NCT ID: NCT01367002
Last Updated: 2023-05-17
Results Overview
Progression free survival differences between treatment arms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
6 years
Results posted on
2023-05-17
Participant Flow
Participant milestones
| Measure |
Carboplatin/Paclitaxel
Chemotherapy
Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
|
Trastuzumab
Monoclonal antibody
Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
32
|
|
Overall Study
Participants Receive Drug
|
28
|
32
|
|
Overall Study
Participants Evaluable for PFS
|
28
|
30
|
|
Overall Study
COMPLETED
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Carboplatin/Paclitaxel
Chemotherapy
Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
|
Trastuzumab
Monoclonal antibody
Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
Baseline characteristics by cohort
| Measure |
Carboplatin/Paclitaxel
n=28 Participants
Chemotherapy
Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
|
Trastuzumab
n=30 Participants
Monoclonal antibody
Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
67 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
30 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Disease Status
Advanced
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Disease Status
Recurrent
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 yearsPopulation: Only patients eligible to be assessed for progression free survival.
Progression free survival differences between treatment arms.
Outcome measures
| Measure |
Carboplatin/Paclitaxel
n=28 Participants
Chemotherapy
Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
|
Trastuzumab
n=30 Participants
Monoclonal antibody
Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
|
|---|---|---|
|
Progression Free Survival Differences Between Treatment Arms.
|
8.049 months
Interval 7.129 to 9.692
|
12.945 months
Interval 10.448 to 18.103
|
SECONDARY outcome
Timeframe: 6 yearsTo assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0. Presented are counts of those that experience any Serious Adverse Events or All Other Adverse Events.
Outcome measures
| Measure |
Carboplatin/Paclitaxel
n=28 Participants
Chemotherapy
Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
|
Trastuzumab
n=32 Participants
Monoclonal antibody
Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
|
|---|---|---|
|
To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0
Serious Adverse Events
|
6 Participants
|
14 Participants
|
|
To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0
All Other Adverse Events
|
28 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: Among those with recurrent disease- see baseline characteristics table.
To assess objective response rate (ORR)
Outcome measures
| Measure |
Carboplatin/Paclitaxel
n=8 Participants
Chemotherapy
Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
|
Trastuzumab
n=9 Participants
Monoclonal antibody
Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
|
|---|---|---|
|
To Assess Objective Response Rate (ORR)
Complete Response (CR)
|
2 Participants
|
1 Participants
|
|
To Assess Objective Response Rate (ORR)
Partial Response (PR)
|
4 Participants
|
3 Participants
|
|
To Assess Objective Response Rate (ORR)
Stable Disease (SD)
|
1 Participants
|
5 Participants
|
|
To Assess Objective Response Rate (ORR)
Progressive Disease (PD)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 yearsTo assess overall survival (OS), presented are the number of participants that survived through the duration of the study period.
Outcome measures
| Measure |
Carboplatin/Paclitaxel
n=28 Participants
Chemotherapy
Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
|
Trastuzumab
n=30 Participants
Monoclonal antibody
Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
|
|---|---|---|
|
To Assess Overall Survival (OS)
|
7 Participants
|
9 Participants
|
Adverse Events
Carboplatin/Paclitaxel
Serious events: 6 serious events
Other events: 28 other events
Deaths: 21 deaths
Trastuzumab
Serious events: 14 serious events
Other events: 32 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Carboplatin/Paclitaxel
n=28 participants at risk
Chemotherapy
Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
|
Trastuzumab
n=32 participants at risk
Monoclonal antibody
Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
3.6%
1/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Sepsis
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Lung infection
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Creatinine increased
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
3.6%
1/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Vascular disorders
Thromboembolic event
|
3.6%
1/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Gastroparesis
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
General disorders
Fever
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
Other adverse events
| Measure |
Carboplatin/Paclitaxel
n=28 participants at risk
Chemotherapy
Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
|
Trastuzumab
n=32 participants at risk
Monoclonal antibody
Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.7%
3/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
4/28 • Number of events 11 • 30 days post treatment (treatment could last as long as 6 years)
|
15.6%
5/32 • Number of events 11 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
2/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
31.2%
10/32 • Number of events 12 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
12.5%
4/32 • Number of events 7 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
3.6%
1/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
15.6%
5/32 • Number of events 12 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.4%
6/28 • Number of events 12 • 30 days post treatment (treatment could last as long as 6 years)
|
31.2%
10/32 • Number of events 16 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
4/28 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
25.0%
8/32 • Number of events 14 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Cognitive disturbance
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Dysgeusia
|
10.7%
3/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
18.8%
6/32 • Number of events 9 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Movements involuntary
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Nervous system disorders - Other
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Neuralgia
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
12.5%
4/32 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
53.6%
15/28 • Number of events 22 • 30 days post treatment (treatment could last as long as 6 years)
|
53.1%
17/32 • Number of events 24 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Syncope
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Nervous system disorders
Tremor
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Psychiatric disorders
Anxiety
|
14.3%
4/28 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
12.5%
4/32 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Psychiatric disorders
Confusion
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Psychiatric disorders
Depression
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
12.5%
4/32 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Psychiatric disorders
Insomnia
|
17.9%
5/28 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
31.2%
10/32 • Number of events 11 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Psychiatric disorders
Restlessness
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
15.6%
5/32 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Cardiac disorders
Sinus tachycardia
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Hematuria
|
10.7%
3/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
21.4%
6/28 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Urinary frequency
|
10.7%
3/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
15.6%
5/32 • Number of events 8 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.6%
1/28 • Number of events 7 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.1%
2/28 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
7.1%
2/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.9%
5/28 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
31.2%
10/32 • Number of events 17 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
6/28 • Number of events 9 • 30 days post treatment (treatment could last as long as 6 years)
|
31.2%
10/32 • Number of events 20 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.6%
1/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
9.4%
3/32 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
2/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
12.5%
4/32 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
14/28 • Number of events 27 • 30 days post treatment (treatment could last as long as 6 years)
|
46.9%
15/32 • Number of events 30 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
4/28 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
12.5%
4/32 • Number of events 7 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
17.9%
5/28 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
21.9%
7/32 • Number of events 9 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Vascular disorders
Flushing
|
3.6%
1/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Vascular disorders
Hot flashes
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Vascular disorders
Hypertension
|
17.9%
5/28 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
34.4%
11/32 • Number of events 22 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Vascular disorders
Hypotension
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Vascular disorders
Thromboembolic event
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Vascular disorders
Vascular disorders - Other
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Vascular disorders
Tinnitus
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Endocrine disorders
Endocrine disorders - Other
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Vascular disorders
Hypothyroidism
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Eye disorders
Blurred vision
|
7.1%
2/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Eye disorders
Dry eye
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Eye disorders
Floaters
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Eye disorders
Glaucoma
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Eye disorders
Retinopathy
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
10.7%
3/28 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
50.0%
16/32 • Number of events 22 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Constipation
|
32.1%
9/28 • Number of events 16 • 30 days post treatment (treatment could last as long as 6 years)
|
53.1%
17/32 • Number of events 26 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Diarrhea
|
17.9%
5/28 • Number of events 12 • 30 days post treatment (treatment could last as long as 6 years)
|
40.6%
13/32 • Number of events 30 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
9.4%
3/32 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
10.7%
3/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
18.8%
6/32 • Number of events 9 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Mucositis oral
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Nausea
|
39.3%
11/28 • Number of events 16 • 30 days post treatment (treatment could last as long as 6 years)
|
56.2%
18/32 • Number of events 52 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
4/28 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
31.2%
10/32 • Number of events 17 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Anal hemorrhage
|
3.6%
1/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
15.6%
5/32 • Number of events 7 • 30 days post treatment (treatment could last as long as 6 years)
|
|
General disorders
Chills
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
General disorders
Fatigue
|
60.7%
17/28 • Number of events 34 • 30 days post treatment (treatment could last as long as 6 years)
|
71.9%
23/32 • Number of events 62 • 30 days post treatment (treatment could last as long as 6 years)
|
|
General disorders
Fever
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
9.4%
3/32 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
|
General disorders
Flu like symptoms
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
General disorders
General disorders and administration site conditions - Other
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
12.5%
4/32 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
|
General disorders
Pain
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
31.2%
10/32 • Number of events 19 • 30 days post treatment (treatment could last as long as 6 years)
|
|
General disorders
Edema limbs
|
14.3%
4/28 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
21.9%
7/32 • Number of events 11 • 30 days post treatment (treatment could last as long as 6 years)
|
|
General disorders
Infusion related reaction
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
General disorders
Localized edema
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Blood and lymphatic system disorders
Anemia
|
46.4%
13/28 • Number of events 33 • 30 days post treatment (treatment could last as long as 6 years)
|
50.0%
16/32 • Number of events 60 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
7.1%
2/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
25.0%
8/32 • Number of events 28 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Immune system disorders
Allergic reaction
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Eye infection
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Infections and infestations - Other
|
7.1%
2/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
12.5%
4/32 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Skin infection
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
9.4%
3/32 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Urinary tract infection
|
14.3%
4/28 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
18.8%
6/32 • Number of events 12 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Vaginal infection
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Wound infection
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Abdominal infection
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Nail infection
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Injury, poisoning and procedural complications
Bruising
|
3.6%
1/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Alanine aminotransferase increased
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
12.5%
4/32 • Number of events 7 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
4/28 • Number of events 7 • 30 days post treatment (treatment could last as long as 6 years)
|
0.00%
0/32 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
9.4%
3/32 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Blood bilirubin increased
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Cholesterol high
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Creatinine increased
|
14.3%
4/28 • Number of events 7 • 30 days post treatment (treatment could last as long as 6 years)
|
28.1%
9/32 • Number of events 21 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Investigations - Other
|
7.1%
2/28 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Lymphocyte count decreased
|
10.7%
3/28 • Number of events 4 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 9 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Neutrophil count decreased
|
32.1%
9/28 • Number of events 38 • 30 days post treatment (treatment could last as long as 6 years)
|
34.4%
11/32 • Number of events 28 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Platelet count decreased
|
21.4%
6/28 • Number of events 8 • 30 days post treatment (treatment could last as long as 6 years)
|
21.9%
7/32 • Number of events 10 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Weight gain
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
9.4%
3/32 • Number of events 9 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Weight loss
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 3 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
White blood cell decreased
|
25.0%
7/28 • Number of events 36 • 30 days post treatment (treatment could last as long as 6 years)
|
18.8%
6/32 • Number of events 45 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
4/28 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
31.2%
10/32 • Number of events 16 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.6%
1/28 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
25.0%
8/32 • Number of events 29 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.6%
1/28 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.1%
2/28 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 1 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
6.2%
2/32 • Number of events 5 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/28 • 30 days post treatment (treatment could last as long as 6 years)
|
3.1%
1/32 • Number of events 2 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.4%
6/28 • Number of events 8 • 30 days post treatment (treatment could last as long as 6 years)
|
12.5%
4/32 • Number of events 6 • 30 days post treatment (treatment could last as long as 6 years)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
8/28 • Number of events 9 • 30 days post treatment (treatment could last as long as 6 years)
|
15.6%
5/32 • Number of events 21 • 30 days post treatment (treatment could last as long as 6 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place