Trial Outcomes & Findings for Dose Dense Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Ovarian Cancer (NCT NCT02440425)
NCT ID: NCT02440425
Last Updated: 2022-10-07
Results Overview
6-month progression-free survival of the combination of weekly paclitaxel with pembrolizumab (MK-3475) for those patients who received treatment and were evaluable (had one response assessment scan by RECIST 1.1) . 6-month PFS: The proportion of patients at 6 months alive without progressive disease. Progressive Disease (PD): Sum of the longest diameters (SLD) increased by at least 20% from the smallest value on study (including baseline, if that is the smallest).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
6 months
Results posted on
2022-10-07
Participant Flow
Participant milestones
| Measure |
Combination Therapy
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
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|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Combination Therapy
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
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|---|---|
|
Overall Study
Death likely due to disease progression
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Adverse Event/Ineligible
|
1
|
Baseline Characteristics
Dose Dense Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Combination Therapy
n=42 Participants
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Evaluable participants
6-month progression-free survival of the combination of weekly paclitaxel with pembrolizumab (MK-3475) for those patients who received treatment and were evaluable (had one response assessment scan by RECIST 1.1) . 6-month PFS: The proportion of patients at 6 months alive without progressive disease. Progressive Disease (PD): Sum of the longest diameters (SLD) increased by at least 20% from the smallest value on study (including baseline, if that is the smallest).
Outcome measures
| Measure |
Combination Therapy
n=37 Participants
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
|
|---|---|
|
Progression-free Survival (PFS) at 6 Months
|
58.6 percentage of participants
Interval 41.0 to 72.7
|
PRIMARY outcome
Timeframe: 2 years, 6 monthsPopulation: All participants who received at least one dose of study drugs.
Safety of the combination of paclitaxel weekly with pembrolizumab every 3 weeks (Q3W). Serious Adverse Events and Adverse Events will be reported in that Results Data section, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4.0.
Outcome measures
| Measure |
Combination Therapy
n=42 Participants
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
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|---|---|
|
Occurrence of Adverse Events
SAEs related to study treatment
|
28 Events
|
|
Occurrence of Adverse Events
AEs related to study treatment
|
573 Events
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Evaluable participants
Proportion of participants who respond to the regimen by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. RECIST v1.1: Complete Response (CR) - Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis. Partial Response (PR) - At least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. RR=CR + PR.
Outcome measures
| Measure |
Combination Therapy
n=37 Participants
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
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|---|---|
|
Response Rate (RR)
|
51.4 percentage of participants
Interval 34.4 to 68.1
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Evaluable participants
DCR: The percentage of participants complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents. Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. DCR=CR + PR + (SD x 2 mo.)
Outcome measures
| Measure |
Combination Therapy
n=37 Participants
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
|
|---|---|
|
Disease Control Rate (DCR)
|
86.5 percentage of participants
Interval 75.5 to 97.5
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Evaluable participants
Duration of Response in months. DOR= Duration from first observation of partial response to the time of disease progression.
Outcome measures
| Measure |
Combination Therapy
n=37 Participants
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
|
|---|---|
|
Duration of Response (DOR)
|
8.8 months
Interval 4.4 to 13.0
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Evaluable participants
OS: The time from randomization until death from any cause.
Outcome measures
| Measure |
Combination Therapy
n=37 Participants
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
|
|---|---|
|
Median Overall Survival (OS)
|
26.3 months
Interval 13.4 to 35.1
|
Adverse Events
Combination Therapy
Serious events: 21 serious events
Other events: 41 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Combination Therapy
n=42 participants at risk
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
|
|---|---|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
2.4%
1/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Cholecystitis
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Urinary tract infection
|
9.5%
4/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Edema
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Edema limbs
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Edema trunk
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Fatigue
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Cough
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Ascites
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Vascular disorders
Hypotension
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Sepsis
|
7.1%
3/42 • Number of events 5 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Fever
|
7.1%
3/42 • Number of events 6 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Spinal fracture
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Infections and Infestations - Other
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Chills
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Infections and Infestations-Other
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Cardiac disorders
Endocarditis
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
Other adverse events
| Measure |
Combination Therapy
n=42 participants at risk
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
|
|---|---|
|
General disorders
Fatigue
|
73.8%
31/42 • Number of events 51 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Edema limbs
|
54.8%
23/42 • Number of events 34 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Fever
|
26.2%
11/42 • Number of events 17 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Pain
|
26.2%
11/42 • Number of events 12 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Non-cardiac chest pain
|
19.0%
8/42 • Number of events 9 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Flu-like symptoms
|
16.7%
7/42 • Number of events 7 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Chills
|
14.3%
6/42 • Number of events 6 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Infusion related reaction
|
9.5%
4/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Edema face
|
7.1%
3/42 • Number of events 3 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Malaise
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Edema trunk
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Facial pain
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
General disorders and administration site conditions - Other
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Infusion site extravasation
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
General disorders
Localized edema
|
2.4%
1/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Blood and lymphatic system disorders
Anemia
|
90.5%
38/42 • Number of events 205 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
21.4%
9/42 • Number of events 23 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Investigations - Other
|
69.0%
29/42 • Number of events 103 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Neutrophil count decreased
|
64.3%
27/42 • Number of events 100 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
White blood cell count decreased
|
54.8%
23/42 • Number of events 121 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Lymphocyte count decreased
|
52.4%
22/42 • Number of events 104 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Alkaline phosphatase increased
|
38.1%
16/42 • Number of events 34 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
14/42 • Number of events 18 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
31.0%
13/42 • Number of events 26 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
12/42 • Number of events 14 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Platelet count decreased
|
26.2%
11/42 • Number of events 17 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Creatinine increased
|
9.5%
4/42 • Number of events 10 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
INR increased
|
9.5%
4/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
CPK increased
|
4.8%
2/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Weight gain
|
4.8%
2/42 • Number of events 3 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Blood bilirubin increased
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Cholesterol high
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Urine output decreased
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Investigations
Weight loss
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
42.9%
18/42 • Number of events 43 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
35.7%
15/42 • Number of events 35 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
14/42 • Number of events 16 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
12/42 • Number of events 18 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.8%
10/42 • Number of events 17 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.8%
10/42 • Number of events 14 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.8%
10/42 • Number of events 15 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
7/42 • Number of events 11 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
7/42 • Number of events 7 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
6/42 • Number of events 6 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
6/42 • Number of events 7 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.9%
5/42 • Number of events 6 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.4%
1/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Nausea
|
54.8%
23/42 • Number of events 38 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Diarrhea
|
45.2%
19/42 • Number of events 35 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
18/42 • Number of events 27 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Bloating
|
31.0%
13/42 • Number of events 19 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Constipation
|
31.0%
13/42 • Number of events 14 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Abdominal pain
|
26.2%
11/42 • Number of events 15 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.9%
5/42 • Number of events 7 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
9.5%
4/42 • Number of events 5 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Mucositis oral
|
9.5%
4/42 • Number of events 5 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Ascites
|
7.1%
3/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
3/42 • Number of events 3 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Rectal pain
|
4.8%
2/42 • Number of events 3 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Dental caries
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
1/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Gastrointestinal disorders
Stomach pain
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
35.7%
15/42 • Number of events 24 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
14/42 • Number of events 14 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
19.0%
8/42 • Number of events 14 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
16.7%
7/42 • Number of events 8 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
6/42 • Number of events 8 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
11.9%
5/42 • Number of events 5 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
9.5%
4/42 • Number of events 6 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
3/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Bulbous dermatitis
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
21/42 • Number of events 32 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
14/42 • Number of events 21 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
7/42 • Number of events 7 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
6/42 • Number of events 12 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
9.5%
4/42 • Number of events 6 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.5%
4/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
2/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Headache
|
23.8%
10/42 • Number of events 11 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.8%
10/42 • Number of events 21 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
21.4%
9/42 • Number of events 12 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Dizziness
|
19.0%
8/42 • Number of events 10 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
3/42 • Number of events 3 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Parasthesia
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Somnolence
|
4.8%
2/42 • Number of events 3 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Syncope
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Amnesia
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Concentration impairment
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Neuralgia
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Presyncope
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Nervous system disorders
Tremor
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.2%
11/42 • Number of events 14 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
7/42 • Number of events 7 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
5/42 • Number of events 5 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.9%
5/42 • Number of events 10 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
9.5%
4/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
3/42 • Number of events 7 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
3/42 • Number of events 3 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, lower limb
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Upper respiratory infection
|
19.0%
8/42 • Number of events 8 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Urinary tract infection
|
19.0%
8/42 • Number of events 10 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Nail infection
|
9.5%
4/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Infections and infestations - Other
|
7.1%
3/42 • Number of events 3 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Sepsis
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Device related infection
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Papulopustular rash
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Pleural infection
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Salivary gland infection
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Infections and infestations
Tooth infection
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Vascular disorders
Hypertension
|
21.4%
9/42 • Number of events 41 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Vascular disorders
Hypotension
|
14.3%
6/42 • Number of events 8 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Vascular disorders
Flushing
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Vascular disorders
Hot flashes
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Vascular disorders
Lymphedema
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Vascular disorders
Superior vena cava syndrome
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Psychiatric disorders
Insomnia
|
19.0%
8/42 • Number of events 9 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Psychiatric disorders
Anxiety
|
11.9%
5/42 • Number of events 5 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Psychiatric disorders
Depression
|
7.1%
3/42 • Number of events 3 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Psychiatric disorders
Confusion
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Psychiatric disorders
Restlessness
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Hematuria
|
9.5%
4/42 • Number of events 6 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Proteniuria
|
9.5%
4/42 • Number of events 8 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Renal and urinary disorders -Other
|
7.1%
3/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
3/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Urinary frequency
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Urinary urgency
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Bladder spasm
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Reproductive system and breast disorders
Pelvic pain
|
14.3%
6/42 • Number of events 6 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Endocrine disorders
Hypothyroidism
|
9.5%
4/42 • Number of events 7 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Endocrine disorders
Hyperthyroidism
|
7.1%
3/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Endocrine disorders
Adrenal insufficiency
|
4.8%
2/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Endocrine disorders
Endocrine disorders - Other
|
2.4%
1/42 • Number of events 2 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Eye disorders
Eye disorders - Other
|
7.1%
3/42 • Number of events 4 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Eye disorders
Watering eyes
|
4.8%
2/42 • Number of events 3 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Eye disorders
Conjunctivitis
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Eye disorders
Eye pain
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Cardiac disorders
Sinus tachycardia
|
9.5%
4/42 • Number of events 7 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Cardiac disorders
Cardiac disorders - Other
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
7.1%
3/42 • Number of events 3 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
|
Hepatobiliary disorders
Hepatobiliary disorders -Other
|
2.4%
1/42 • Number of events 1 • Adverse events were recorded from Day 1 of treatment through Day 90 after treatment, 4 years, 6 months. All participants who received at least one dose of study drug are included.
|
Additional Information
Robert M. Wenham, MD, MS, FACOG, FACS
Moffitt Cancer Center
Phone: 813-745-5739
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The study may be presented at scientific meetings by any of the study investigators with the approval of the Sponsor and also allowing time for prior review by Merck. Intent to submit should be made no later than 4 weeks before a submission is due, and a copy of an abstract or presentation should be submitted no later than 3 weeks prior to finalization or submission to allow time to review.
- Publication restrictions are in place
Restriction type: OTHER