Trial Outcomes & Findings for A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer (NCT NCT01610206)
NCT ID: NCT01610206
Last Updated: 2021-02-25
Results Overview
Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of recurrence/progression or death from any cause, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
148 participants
Primary outcome timeframe
3 years
Results posted on
2021-02-25
Participant Flow
Participant milestones
| Measure |
Gemcitabine
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
|
Gemcitabine + Pazopanib
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
75
|
|
Overall Study
COMPLETED
|
63
|
45
|
|
Overall Study
NOT COMPLETED
|
10
|
30
|
Reasons for withdrawal
| Measure |
Gemcitabine
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
|
Gemcitabine + Pazopanib
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
30
|
Baseline Characteristics
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine
n=73 Participants
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
|
Gemcitabine + Pazopanib
n=75 Participants
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
63 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=5 Participants
|
75 participants
n=7 Participants
|
148 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsProgression-Free Survival (PFS) is defined as the duration of time from study entry to time of recurrence/progression or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Gemcitabine
n=73 Participants
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
|
Gemcitabine + Pazopanib
n=75 Participants
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
|
|---|---|---|
|
Progression-free Survival
|
2.9 months
Interval 2.1 to 4.1
|
5.3 months
Interval 4.2 to 5.8
|
SECONDARY outcome
Timeframe: 30 days after last doseAdverse events will be evaluated using CTCAE criteria from the start of study treatment until 30 days following the last dose of study treatment
Outcome measures
| Measure |
Gemcitabine
n=73 Participants
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
|
Gemcitabine + Pazopanib
n=75 Participants
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
|
|---|---|---|
|
Number of Participants With Adverse Events
|
73 Participants
|
75 Participants
|
Adverse Events
Gemcitabine
Serious events: 20 serious events
Other events: 73 other events
Deaths: 54 deaths
Gemcitabine + Pazopanib
Serious events: 63 serious events
Other events: 75 other events
Deaths: 63 deaths
Serious adverse events
| Measure |
Gemcitabine
n=73 participants at risk
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
|
Gemcitabine + Pazopanib
n=75 participants at risk
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
10.7%
8/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Neutropenia
|
20.5%
15/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
40.0%
30/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Thrombocytopenia
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
14.7%
11/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Fatigue
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
12.0%
9/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Elevated AST
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
12.0%
9/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Vascular disorders
Hypertension
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
16.0%
12/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Fever
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
0.00%
0/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
ALT increased
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
12.0%
9/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Decreased lymphocyte count
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
White blood cell count
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
14.7%
11/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
6.7%
5/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
Other adverse events
| Measure |
Gemcitabine
n=73 participants at risk
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
|
Gemcitabine + Pazopanib
n=75 participants at risk
Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
35.6%
26/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
14.7%
11/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Cardiac disorders
heart failure
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Ear and labyrinth disorders
tinnitus
|
4.1%
3/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Eye disorders
blurred vision
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
9.3%
7/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
5.3%
4/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Constipation
|
9.6%
7/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
13.3%
10/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
9.6%
7/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
32.0%
24/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
6.7%
5/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.5%
4/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
17.3%
13/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Nausea
|
24.7%
18/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
46.7%
35/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
5/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
25.3%
19/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Chills
|
5.5%
4/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
8.0%
6/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Edema face
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Edema limbs
|
5.5%
4/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
6.7%
5/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Fatigue
|
38.4%
28/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
54.7%
41/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Fever
|
5.5%
4/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
5.3%
4/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Flu-like symptoms
|
4.1%
3/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
5.3%
4/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Infusion related reaction
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
0.00%
0/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Injection site reaction
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Non-cardiac chest pain
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
General disorders
Pain
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Infections and infestations
Upper respiratory infection
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
0.00%
0/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Alanine Aminotransferase increased
|
6.8%
5/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
20.0%
15/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Alkaline Phosphatase increased
|
4.1%
3/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
16.0%
12/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Aspartate Aminotransferase increased
|
6.8%
5/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
29.3%
22/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Creatinine increased
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
8.0%
6/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Neutrophil count decreased
|
5.5%
4/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
10.7%
8/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Platelet count decreased
|
4.1%
3/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
16.0%
12/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
Weight loss
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
5.3%
4/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Investigations
White blood cell decreased
|
4.1%
3/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
18.7%
14/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.3%
9/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
28.0%
21/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
6.7%
5/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesmia
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
4.0%
3/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
9.3%
7/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
4.0%
3/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
9.3%
7/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
4/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
4.0%
3/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.1%
3/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
6.7%
5/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.1%
3/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
8.0%
6/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
6.7%
5/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Nervous system disorders
Dysgeusia
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
8.0%
6/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Nervous system disorders
Headache
|
8.2%
6/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
22.7%
17/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Nervous system disorders
Paresthesia
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
10.7%
8/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Psychiatric disorders
Insomnia
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
0.00%
0/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Renal and urinary disorders
Hematuria
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
0.00%
0/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
0.00%
0/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Reproductive system and breast disorders
Dyspareunia
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
0.00%
0/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
3/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
9.3%
7/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.1%
3/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
18.7%
14/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
4.0%
3/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
9.3%
7/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysethesia syndrome
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
6.7%
5/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.4%
1/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
6.7%
5/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Vascular disorders
Hot flashes
|
2.7%
2/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
22.7%
17/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
1.3%
1/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/73 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
2.7%
2/75 • Adverse events were collected from the time the first study-related procedure was performed until 30 days post administration of the last study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60