Trial Outcomes & Findings for Study of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer (NCT NCT02025010)
NCT ID: NCT02025010
Last Updated: 2025-04-15
Results Overview
Patients requiring prednisone to manage toxicities such as COU-302 any grade or COU-301 grade 3-4 hypertension, hypokalemia and edema per CTCAE v. 4.0 were summarized using frequency and percentage.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Patients were on abiraterone acetate up to 57 months and toxicities of mineralocorticoid excess were monitored each cycle (1cycle = 28 days).
Results posted on
2025-04-15
Participant Flow
Participant milestones
| Measure |
Abiraterone Acetate
Participants will be treated with four 250 mg tablets (1,000 mg) of abiraterone acetate (AA) orally on 28 day cycles. For participants who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression, prednisone 5 mg by mouth twice daily will be added.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
Abiraterone Acetate
Participants will be treated with four 250 mg tablets (1,000 mg) of abiraterone acetate (AA) orally on 28 day cycles. For participants who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression, prednisone 5 mg by mouth twice daily will be added.
|
|---|---|
|
Overall Study
Symptomatic or radiographic progression
|
36
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Physician Decision
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Intercurrent illness
|
3
|
|
Overall Study
Patients still on treatment
|
3
|
|
Overall Study
Never initiate the treatment
|
2
|
Baseline Characteristics
Study of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Abiraterone Acetate
n=58 Participants
Participants will be treated with four 250 mg tablets (1,000 mg) of abiraterone acetate (AA) orally on 28 day cycles. For participants who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression, prednisone 5 mg by mouth twice daily will be added.
|
|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Baseline antihypertensive use
Any
|
26 Participants
n=5 Participants
|
|
Baseline antihypertensive use
1 agent
|
15 Participants
n=5 Participants
|
|
Baseline antihypertensive use
2 agents
|
8 Participants
n=5 Participants
|
|
Baseline antihypertensive use
3 agents
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients were on abiraterone acetate up to 57 months and toxicities of mineralocorticoid excess were monitored each cycle (1cycle = 28 days).Population: Participants who received at least 1 dose of abiraterone acetate.
Patients requiring prednisone to manage toxicities such as COU-302 any grade or COU-301 grade 3-4 hypertension, hypokalemia and edema per CTCAE v. 4.0 were summarized using frequency and percentage.
Outcome measures
| Measure |
Abiraterone Acetate
n=58 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess
Any grade mineralocorticoid toxicities
|
38 Participants
|
—
|
|
Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess
Any grade hypertension
|
28 Participants
|
—
|
|
Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess
Any grade hypokalemia
|
15 Participants
|
—
|
|
Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess
Any grade edema
|
11 Participants
|
—
|
|
Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess
Grade 3-4 mineralocorticoid toxicities
|
12 Participants
|
—
|
|
Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess
Grade 3-4 hypertension
|
9 Participants
|
—
|
|
Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess
Grade 3-4 hypokalemia
|
4 Participants
|
—
|
|
Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess
Grade 3-4 edema
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Adverse events were assessed continuously on treatment and up to 30 days after going off treatment (up to 55 months).Population: Patients who initiated at least one dose of abiraterone acetate. Prednisone was co-administered for 35 patients who experienced symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle.
Grade 3 or higher toxicities attribution to AA monotherapy with or without prednisone were summarized descriptively.
Outcome measures
| Measure |
Abiraterone Acetate
n=58 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
n=35 Participants
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
Grade 3 Rash pustular
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
Grade 3 Anemia
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
Grade 3 Depression
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
Grade 3 Hypertension
|
9 Participants
|
2 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
Grade 3 Hypokalemia
|
2 Participants
|
2 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
Grade 3 Mood Alteration
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
Grade 4 Hypertension
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
Grade 3 Alanine aminotransferase increased
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
Grade 3 Aspartate aminotransferase increased
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
Grade 3 Fatigue
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
Grade 3 Gastrointestinal Bleed
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
AE grade <3
|
40 Participants
|
27 Participants
|
|
Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.
No AE reported post baseline
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Patients were on abiraterone acetate up to 57 months.Population: Patients receiving at least 1 dose of abiraterone acetate.
Participants initiated treatment with prednisone for ≥grade 3 fatigue were summarized using frequency and percentage.
Outcome measures
| Measure |
Abiraterone Acetate
n=58 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Number of Participants Requiring the Addition of Prednisone to Manage Symptoms of Severe Fatigue.
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Patients who received at least one dose of abiraterone acetate and had available serum concentrations of corticosteroid.
Percent change in corticosterone level between the first visit and the second visit was summarized by whether patients initiated prednisone for hypertension and hypokalemia.
Outcome measures
| Measure |
Abiraterone Acetate
n=56 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Changes in Serum Concentrations of Corticosteroid Intermediates Between the First and Second Assessment Visits.
Patients without prednisone
|
58 Percentage
Interval 30.0 to 93.0
|
—
|
|
Changes in Serum Concentrations of Corticosteroid Intermediates Between the First and Second Assessment Visits.
Patients with prednisone
|
116 Percentage
Interval 30.0 to 248.0
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Patients receiving at least one dose of abiraterone acetate
Changes in serum concentrations of ACTH at second assessment referent to the value at the first visit were summarized descriptively.
Outcome measures
| Measure |
Abiraterone Acetate
n=58 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Changes in Serum Concentrations of ACTH Between Cycle 1 and Cycle 2.
|
0 pg/mL
Interval 0.0 to 49.5
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Patients who initiated abiraterone acetate (n=58) and had available each serum hormone data at cycles 1 and 2 (can be smaller than 58).
Change in corticosterone level between cycle 2 and cycle 1 was summarized by whether patients initiated prednisone for hypertension and hypokalemia.
Outcome measures
| Measure |
Abiraterone Acetate
n=58 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Pregnenolone change among patients with prednisone
|
23.4 Percent change
Interval 18.9 to 31.4
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Progesterone change among patients without prednisone
|
96.3 Percent change
Interval 31.0 to 132.5
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Progesterone change among patients with prednisone
|
104.6 Percent change
Interval 63.7 to 201.5
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Androstenedione change among patients without prednisone
|
-0.97 Percent change
Interval -0.99 to -0.94
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Androstenedione change among patients with prednisone
|
-0.97 Percent change
Interval -0.98 to -0.94
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Androsterone change among patients without prednisone
|
-0.91 Percent change
Interval -0.95 to -0.82
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Androsterone change among patients with prednisone
|
-0.87 Percent change
Interval -0.93 to -0.79
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Corticosterone change among patients without prednisone
|
42.7 Percent change
Interval 16.9 to 93.4
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Corticosterone change among patients with prednisone
|
51.7 Percent change
Interval 34.3 to 96.4
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Cortisol change among patients without prednisone
|
-0.58 Percent change
Interval -0.81 to -0.46
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Cortisol change among patients with prednisone
|
-0.73 Percent change
Interval -0.79 to -0.66
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
DHEA change among patients without prednisone
|
-0.98 Percent change
Interval -0.99 to -0.95
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
DHEA change among patients with prednisone
|
-0.99 Percent change
Interval -0.99 to -0.97
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
DHT change among patients without prednisone
|
-0.37 Percent change
Interval -0.52 to 0.0
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
DHT change among patients with prednisone
|
-0.29 Percent change
Interval -0.47 to 0.0
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
11 Deoxycorticosterone change among patients without prednisone
|
40.3 Percent change
Interval 21.7 to 83.2
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
11 Deoxycorticosterone change among patients with prednisone
|
47.8 Percent change
Interval 33.0 to 77.5
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
11 Deoxycortisol change among patients without prednisone
|
-0.61 Percent change
Interval -0.79 to -0.43
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
11 Deoxycortisol % change among patients with prednisone
|
-0.71 Percent change
Interval -0.86 to -0.64
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
17 Hydroxypregnenolone % change among patients without prednisone
|
0 Percent change
Interval -0.12 to 1.23
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
17 Hydroxypregnenolone % change among patients with prednisone
|
0 Percent change
Interval -0.19 to 0.59
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
17 Hydroxyprogesterone change among patients without prednisone
|
0.02 Percent change
Interval -0.41 to 0.92
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
17 Hydroxyprogesterone change among patients with prednisone
|
0.06 Percent change
Interval -0.32 to 0.67
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Pregnenolone change among patients without prednisone
|
19.0 Percent change
Interval 15.5 to 25.8
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Testosterone change among patients without prednisone
|
0.07 Percent change
Interval 0.04 to 0.1
|
—
|
|
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Testosterone change among patients with prednisone
|
0.07 Percent change
Interval 0.06 to 0.08
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Patients receiving at least one dose of abiraterone acetate.
Changes in BMI between cycle 1 and cycle 2 were summarized descriptively.
Outcome measures
| Measure |
Abiraterone Acetate
n=58 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Changes in BMI Between Cycle 1 and Next Cycle
|
0 kg/m²
Interval 0.0 to 0.15
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Patients receiving at least one dose of abiraterone acetate.
Changes in HbA1c at cycle 1 and next measurement at cycle 4 were summarized descriptively.
Outcome measures
| Measure |
Abiraterone Acetate
n=58 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Changes in Hemoglobin-A1c Between Cycle 1 and Next Cycle (Cycle 4)
|
0 Percentage of glycated hemoglobin
Interval -0.2 to 0.0
|
—
|
SECONDARY outcome
Timeframe: PSA was measured every cycle (up to 25 months)Population: PSA responders after receiving at least one dose of abiraterone acetate without prednisone
PSA response was defined per PCWG2 criteria (PSA reduction of ≥50%) and duration of PSA response is defined as time from PSA response to PSA progression or death, whichever occurs first.
Outcome measures
| Measure |
Abiraterone Acetate
n=22 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
PSA Response and Its Duration to AA Monotherapy.
|
3 months
Interval 1.0 to 18.0
|
—
|
SECONDARY outcome
Timeframe: PSA was measured every cycle (up to 25 months)Population: Patients who achieved a PSA response and initiated prednisone at PSA progression
Among those who initiated prednisone due to PSA progression, duration of PSA response was calculated as time from PSA response (PSA reduction ≥50%) to PSA progression or death, whichever occurs first.
Outcome measures
| Measure |
Abiraterone Acetate
n=22 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
PSA Response and Its Duration to Addition of Prednisone to AA at Time of PSA Progression on AA Monotherapy.
|
5 months
Interval 2.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Imaging was performed every 12 weeks up to 23 months.Population: Patients who received at least 1 dose of abiraterone acetate without prednisone and had a measurable disease at baseline.
Radiographic response of measurable disease is defined using RECIST v 1.1 for soft-tissue and visceral disease and PCWG2 for bone disease. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Response is tabulated descriptively.
Outcome measures
| Measure |
Abiraterone Acetate
n=11 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Response of Measurable Disease to AA Monotherapy.
Complete response
|
1 Participants
|
—
|
|
Response of Measurable Disease to AA Monotherapy.
Partial response
|
2 Participants
|
—
|
|
Response of Measurable Disease to AA Monotherapy.
Stable disease
|
4 Participants
|
—
|
|
Response of Measurable Disease to AA Monotherapy.
Progressive disease
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Imaging was performed every 12 weeks up to 23 months.Population: Patients who received at least 1 dose of abiraterone acetate without prednisone and had a measurable disease at baseline.
Radiographic disease progression is defined using RECIST v 1.1 for soft-tissue and visceral disease and PCWG2 for bone disease (2 or more new lesions on bone scan and for the first 12-week assessment, defining disease progression requires a confirmatory scan performed 6 or more weeks later which shows a minimum of 2 additional new lesions).
Outcome measures
| Measure |
Abiraterone Acetate
n=11 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Number of Patients Who Received AA Monotherapy and Progressed With Measurable Disease at Pre-study
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Imaging was performed every 12 weeks up to 23 months.Population: Patients who received at least one dose of abiraterone acetate with prednisone at PSA progression and had a measurable disease at baseline.
Radiographic response of measurable disease is defined using RECIST v 1.1 for soft-tissue and visceral disease and PCWG2 for bone disease. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Response is tabulated descriptively.
Outcome measures
| Measure |
Abiraterone Acetate
n=10 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Response of Measurable Disease to Addition of Prednisone to AA at Time of PSA Progression on AA Monotherapy.
Complete response
|
3 Participants
|
—
|
|
Response of Measurable Disease to Addition of Prednisone to AA at Time of PSA Progression on AA Monotherapy.
Partial response
|
1 Participants
|
—
|
|
Response of Measurable Disease to Addition of Prednisone to AA at Time of PSA Progression on AA Monotherapy.
Stable disease
|
5 Participants
|
—
|
|
Response of Measurable Disease to Addition of Prednisone to AA at Time of PSA Progression on AA Monotherapy.
Progressive disease
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Imaging was performed every 12 weeks up to 23 months.Population: Patients who received at least one dose of abiraterone acetate with prednisone at PSA progression and had a measurable disease at baseline.
Radiographic response of measurable disease is defined using RECIST v 1.1 for soft-tissue and visceral disease and PCWG2 for bone disease. Due to small number patients, patients who experienced progressive disease were summarized using frequency and time to progression using Kaplan-Meier method was not calculated.
Outcome measures
| Measure |
Abiraterone Acetate
n=10 Participants
Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia). For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added.
|
Abiraterone Acetate + Prednisone
Prednisone 5mg by mouth twice was co-administered with abiraterone acetate for those who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression at any cycle. This is subset of the patients who initiated abiraterone acetate (n=58).
|
|---|---|---|
|
Number of Patients Who Progressed With Measurable Disease at Pre-study Among Those Who Were Added of Prednisone to AA at Time of PSA Progression on AA Monotherapy.
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Data not collected.Population: Data not collected.
Subsequent lines of therapy following study drug discontinuation were not collected for this trial.
Outcome measures
Outcome data not reported
Adverse Events
Abiraterone Acetate
Serious events: 9 serious events
Other events: 60 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Abiraterone Acetate
n=60 participants at risk
Participants will be treated with four 250 mg tablets (1,000 mg) of abiraterone acetate (AA) orally on 28 day cycles. For participants who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression, prednisone 5 mg by mouth twice daily will be added.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Heart failure
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
General disorders
Pain
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Lung infection
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Creatinine increased
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
Other adverse events
| Measure |
Abiraterone Acetate
n=60 participants at risk
Participants will be treated with four 250 mg tablets (1,000 mg) of abiraterone acetate (AA) orally on 28 day cycles. For participants who experience symptoms of persistent or severe mineralocorticoid excess or PSA progression, prednisone 5 mg by mouth twice daily will be added.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
4/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Chest pain - cardiac
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Heart failure
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Palpitations
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Sinus bradycardia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
6.7%
4/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Ear and labyrinth disorders
Ear pain
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
3/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Ear and labyrinth disorders
Vertigo
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Eye disorders
Blurred vision
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Eye disorders
Optic nerve disorder
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Eye disorders
Eye disorders - Other, specify
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Constipation
|
15.0%
9/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
5/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Enterocolitis
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
5/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Nausea
|
13.3%
8/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Stomach pain
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Toothache
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
3/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.7%
4/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
General disorders
Chills
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
General disorders
Edema limbs
|
18.3%
11/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
General disorders
Edema trunk
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
General disorders
Fatigue
|
75.0%
45/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
General disorders
Fever
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
General disorders
Gait disturbance
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
General disorders
Localized edema
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
General disorders
Non-cardiac chest pain
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
General disorders
Pain
|
36.7%
22/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Papulopustular rash
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Prostate infection
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Rash pustular
|
5.0%
3/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Sinusitis
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Skin infection
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Tooth infection
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
6/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Urinary tract infection
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Wound infection
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.7%
4/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Injury, poisoning and procedural complications
Bruising
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
6/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Alkaline phosphatase increased
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
12/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Blood bilirubin increased
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Creatinine increased
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Lipase increased
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Neutrophil count decreased
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Platelet count decreased
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Serum amylase increased
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Weight gain
|
5.0%
3/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Investigations
Weight loss
|
6.7%
4/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
3/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
4/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.0%
3/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.0%
21/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
4/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.7%
13/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
4/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
5/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
5/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
6/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
13.3%
8/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Dizziness
|
13.3%
8/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Dysgeusia
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Headache
|
11.7%
7/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Paresthesia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.7%
7/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Syncope
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.0%
3/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Psychiatric disorders
Anxiety
|
8.3%
5/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Psychiatric disorders
Depression
|
8.3%
5/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Psychiatric disorders
Insomnia
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Psychiatric disorders
Restlessness
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
5.0%
3/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Hematuria
|
5.0%
3/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Renal calculi
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Urinary frequency
|
25.0%
15/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Urinary incontinence
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Urinary tract pain
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Urinary urgency
|
5.0%
3/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
11.7%
7/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Reproductive system and breast disorders
Gynecomastia
|
5.0%
3/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
12/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.3%
11/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.3%
8/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
3.3%
2/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Vascular disorders
Hot flashes
|
43.3%
26/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Vascular disorders
Hypertension
|
51.7%
31/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
|
Vascular disorders
Hypotension
|
1.7%
1/60 • Toxicities were assessed every cycle and up to 30 days after coming off treatment. Toxicities were collected up to around 55 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. Requires or prolongs inpatient hospitalization Results in persistent or significant disability/incapacity
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place