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Trial Outcomes & Findings for A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer (NCT NCT00320541)

NCT ID: NCT00320541

Last Updated: 2013-07-22

Results Overview

Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

187 participants

Primary outcome timeframe

baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)

Results posted on

2013-07-22

Participant Flow

219 patients were screened; 28 patients were screen failures and were not assigned treatment.

Participant milestones

Participant milestones
Measure
Paclitaxel Plus Bevacizumab (PB)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Study
STARTED
94
93
Overall Study
COMPLETED
44
36
Overall Study
NOT COMPLETED
50
57

Reasons for withdrawal

Reasons for withdrawal
Measure
Paclitaxel Plus Bevacizumab (PB)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Study
Adverse Event
21
19
Overall Study
Protocol Violation
0
1
Overall Study
Withdrawal by Subject
12
16
Overall Study
Physician Decision
9
13
Overall Study
Other
3
4
Overall Study
Sponsor Decision
2
1
Overall Study
Death due to Study Disease
1
3
Overall Study
Death due to Adverse Event(s)
1
0
Overall Study
Protocol Entry Criterion Not Met
1
0

Baseline Characteristics

A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Paclitaxel Plus Bevacizumab (PB)
n=94 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=93 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Total
n=187 Participants
Total of all reporting groups
Age Continuous
57.5 years
STANDARD_DEVIATION 10.68 • n=99 Participants
56.8 years
STANDARD_DEVIATION 9.56 • n=107 Participants
57.2 years
STANDARD_DEVIATION 10.12 • n=206 Participants
Sex: Female, Male
Female
94 Participants
n=99 Participants
93 Participants
n=107 Participants
187 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race/Ethnicity, Customized
Caucasian
80 participants
n=99 Participants
77 participants
n=107 Participants
157 participants
n=206 Participants
Race/Ethnicity, Customized
African
5 participants
n=99 Participants
11 participants
n=107 Participants
16 participants
n=206 Participants
Race/Ethnicity, Customized
Hispanic
7 participants
n=99 Participants
4 participants
n=107 Participants
11 participants
n=206 Participants
Race/Ethnicity, Customized
East Asian
2 participants
n=99 Participants
1 participants
n=107 Participants
3 participants
n=206 Participants
Region of Enrollment
United States
94 participants
n=99 Participants
93 participants
n=107 Participants
187 participants
n=206 Participants
Basis for Pathological Diagnosis
Histopathological
84 participants
n=99 Participants
84 participants
n=107 Participants
168 participants
n=206 Participants
Basis for Pathological Diagnosis
Cytological
10 participants
n=99 Participants
8 participants
n=107 Participants
18 participants
n=206 Participants
Basis for Pathological Diagnosis
Missing
0 participants
n=99 Participants
1 participants
n=107 Participants
1 participants
n=206 Participants
Breakdown According to Eastern Cooperative Oncology Group (ECOG) Performance Status
Fully Active- 0
57 participants
n=99 Participants
60 participants
n=107 Participants
117 participants
n=206 Participants
Breakdown According to Eastern Cooperative Oncology Group (ECOG) Performance Status
Ambulatory, Restricted Strenuous Activity- 1
37 participants
n=99 Participants
31 participants
n=107 Participants
68 participants
n=206 Participants
Breakdown According to Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
0 participants
n=99 Participants
2 participants
n=107 Participants
2 participants
n=206 Participants
Breakdown by Estrogen Receptor (ER) Status
Positive
60 participants
n=99 Participants
67 participants
n=107 Participants
127 participants
n=206 Participants
Breakdown by Estrogen Receptor (ER) Status
Negative
33 participants
n=99 Participants
25 participants
n=107 Participants
58 participants
n=206 Participants
Breakdown by Estrogen Receptor (ER) Status
Unknown
1 participants
n=99 Participants
1 participants
n=107 Participants
2 participants
n=206 Participants
Breakdown by Human Epidermal Growth Factor (HER-2 NEU) Status
Not done
3 participants
n=99 Participants
4 participants
n=107 Participants
7 participants
n=206 Participants
Breakdown by Human Epidermal Growth Factor (HER-2 NEU) Status
Positive
4 participants
n=99 Participants
2 participants
n=107 Participants
6 participants
n=206 Participants
Breakdown by Human Epidermal Growth Factor (HER-2 NEU) Status
Negative
87 participants
n=99 Participants
86 participants
n=107 Participants
173 participants
n=206 Participants
Breakdown by Human Epidermal Growth Factor (HER-2 NEU) Status
Missing
0 participants
n=99 Participants
1 participants
n=107 Participants
1 participants
n=206 Participants
Breakdown by Progesterone Receptor (PR) Status
Not done
1 participants
n=99 Participants
0 participants
n=107 Participants
1 participants
n=206 Participants
Breakdown by Progesterone Receptor (PR) Status
Positive
42 participants
n=99 Participants
57 participants
n=107 Participants
99 participants
n=206 Participants
Breakdown by Progesterone Receptor (PR) Status
Negative
50 participants
n=99 Participants
35 participants
n=107 Participants
85 participants
n=206 Participants
Breakdown by Progesterone Receptor (PR) Status
Unknown
1 participants
n=99 Participants
1 participants
n=107 Participants
2 participants
n=206 Participants
Breakdown of Disease-free Interval
Less than or equal to 24 months
5 participants
n=99 Participants
10 participants
n=107 Participants
15 participants
n=206 Participants
Breakdown of Disease-free Interval
Greater than 24 months
6 participants
n=99 Participants
2 participants
n=107 Participants
8 participants
n=206 Participants
Breakdown of Disease-free Interval
Not applicable
83 participants
n=99 Participants
81 participants
n=107 Participants
164 participants
n=206 Participants
Diagnosis by pathology
Ductal breast carcinoma
76 participants
n=99 Participants
79 participants
n=107 Participants
155 participants
n=206 Participants
Diagnosis by pathology
Lobal breast carcinoma
9 participants
n=99 Participants
6 participants
n=107 Participants
15 participants
n=206 Participants
Diagnosis by pathology
Tubal breast carcinoma
0 participants
n=99 Participants
0 participants
n=107 Participants
0 participants
n=206 Participants
Diagnosis by pathology
Medullary breast carcinoma
0 participants
n=99 Participants
0 participants
n=107 Participants
0 participants
n=206 Participants
Diagnosis by pathology
Adenocystic breast carcinoma
0 participants
n=99 Participants
0 participants
n=107 Participants
0 participants
n=206 Participants
Diagnosis by pathology
Papillar breast carcinoma
0 participants
n=99 Participants
0 participants
n=107 Participants
0 participants
n=206 Participants
Diagnosis by pathology
Breast carcinoma
6 participants
n=99 Participants
3 participants
n=107 Participants
9 participants
n=206 Participants
Diagnosis by pathology
Other
3 participants
n=99 Participants
5 participants
n=107 Participants
8 participants
n=206 Participants
Menopausal Status
Not done
1 participants
n=99 Participants
1 participants
n=107 Participants
2 participants
n=206 Participants
Menopausal Status
Pre-menopausal
18 participants
n=99 Participants
18 participants
n=107 Participants
36 participants
n=206 Participants
Menopausal Status
Peri-menopausal
2 participants
n=99 Participants
3 participants
n=107 Participants
5 participants
n=206 Participants
Menopausal Status
Post-menopausal
73 participants
n=99 Participants
70 participants
n=107 Participants
143 participants
n=206 Participants
Menopausal Status
Unknown
0 participants
n=99 Participants
1 participants
n=107 Participants
1 participants
n=206 Participants
Presence of Visceral Metastases
Yes
68 participants
n=99 Participants
66 participants
n=107 Participants
134 participants
n=206 Participants
Presence of Visceral Metastases
No
25 participants
n=99 Participants
24 participants
n=107 Participants
49 participants
n=206 Participants
Presence of Visceral Metastases
Missing
1 participants
n=99 Participants
3 participants
n=107 Participants
4 participants
n=206 Participants
Prior Biological Treatment for This Cancer
0 participants
n=99 Participants
2 participants
n=107 Participants
2 participants
n=206 Participants
Prior Cancer Surgery
79 participants
n=99 Participants
82 participants
n=107 Participants
161 participants
n=206 Participants
Prior Chemotherapy for This Cancer
55 participants
n=99 Participants
57 participants
n=107 Participants
112 participants
n=206 Participants
Prior Exposure to Taxanes
Yes
33 participants
n=99 Participants
32 participants
n=107 Participants
65 participants
n=206 Participants
Prior Exposure to Taxanes
No
61 participants
n=99 Participants
61 participants
n=107 Participants
122 participants
n=206 Participants
Prior Hormonal Treatment for This Cancer
51 participants
n=99 Participants
53 participants
n=107 Participants
104 participants
n=206 Participants
Prior Immunological Treatment for This Cancer
2 participants
n=99 Participants
0 participants
n=107 Participants
2 participants
n=206 Participants
Prior Radiotherapy
50 participants
n=99 Participants
55 participants
n=107 Participants
105 participants
n=206 Participants
Body Surface Area (BSA) at Day 1 of Visit 1
1.8 square meters (m2)
STANDARD_DEVIATION 0.18 • n=99 Participants
1.8 square meters (m2)
STANDARD_DEVIATION 0.21 • n=107 Participants
1.8 square meters (m2)
STANDARD_DEVIATION 0.20 • n=206 Participants

PRIMARY outcome

Timeframe: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)

Population: Per-protocol population included intent-to-treat participants who met the following criteria: histological or cytological breast cancer diagnosis; baseline presence of measurable disease per RECIST; at least 1 dose of study drug; no current systemic anti-tumor therapy except protocol-specified therapy. One PB+G participant did not qualify.

Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).

Outcome measures

Outcome measures
Measure
Paclitaxel Plus Bevacizumab (PB)
n=94 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=92 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Response Rate (ORR)
0.489 proportion of responders
Interval 0.385 to 0.595
0.587 proportion of responders
Interval 0.479 to 0.689

SECONDARY outcome

Timeframe: baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated)

Population: ITT population=all randomized participants, eligible \& ineligible. Participants with events: PB=74; PB+G=72. Censored participants: PB=20 PB+G=21.

PFS was measured from date of randomization to first date of disease progression or death from any cause. For participants not known to have died or had disease progression as of data-inclusion cut-off date, PFS duration was censored at date of last study visit prior to data-inclusion cut-off date.

Outcome measures

Outcome measures
Measure
Paclitaxel Plus Bevacizumab (PB)
n=94 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=93 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Progression-free Survival (PFS)
8.8 months
Interval 0.1 to 27.3
11.3 months
Interval 1.5 to 33.8

SECONDARY outcome

Timeframe: baseline to death from any cause (up to 35 months)

Population: Intent-To-Treat (ITT) population=all randomized participants, eligible \& ineligible. Number of participants with events: PB=35; PB+G=34. Censored participants: PB=59;PB+G=59.

Overall survival was measured from date of randomization to date of death from any cause. For participants not known to have died as of data-inclusion cut-off date, overall survival duration was censored at date of last study visit prior to the data cut-off date.

Outcome measures

Outcome measures
Measure
Paclitaxel Plus Bevacizumab (PB)
n=94 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=93 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Survival
25.0 months
Interval 0.1 to 34.6
24.3 months
Interval 1.5 to 33.8

SECONDARY outcome

Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Population: Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment

FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), \& additional concerns of breast cancer (BCS). Total FACT-B scores range from 0-144, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for FACT-B is 7-8 points. FACT-B was assessed at baseline (prior to start of Cycle 1 \[Day 1\]), prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

Outcome measures

Outcome measures
Measure
Paclitaxel Plus Bevacizumab (PB)
n=60 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=55 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy
-1.0 units on a scale
Standard Deviation 15.10
-10.8 units on a scale
Standard Deviation 16.87

SECONDARY outcome

Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Population: Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment

The PWB subscale of FACT-B measures physical well-being. Total PWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 \[Day 1\]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

Outcome measures

Outcome measures
Measure
Paclitaxel Plus Bevacizumab (PB)
n=60 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=56 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy
-1.9 units on a scale
Standard Deviation 5.90
-4.0 units on a scale
Standard Deviation 6.00

SECONDARY outcome

Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Population: Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment

The SFWB subscale of FACT-B measures social/family well-being. Total SFWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 \[Day 1\]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

Outcome measures

Outcome measures
Measure
Paclitaxel Plus Bevacizumab (PB)
n=61 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=56 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy
0.0 units on a scale
Standard Deviation 3.43
-1.9 units on a scale
Standard Deviation 3.61

SECONDARY outcome

Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Population: Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment

The EWB subscale of FACT-B measures emotional well-being. Total EWB scores range from 0 to 24, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 \[Day 1\]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

Outcome measures

Outcome measures
Measure
Paclitaxel Plus Bevacizumab (PB)
n=61 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=56 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy
1.8 units on a scale
Standard Deviation 3.17
-0.2 units on a scale
Standard Deviation 3.88

SECONDARY outcome

Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Population: Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment

The FWB subscale of FACT-B measures functional well-being. Total FWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 \[Day 1\]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

Outcome measures

Outcome measures
Measure
Paclitaxel Plus Bevacizumab (PB)
n=61 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=55 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy
-0.3 units on a scale
Standard Deviation 5.38
-3.8 units on a scale
Standard Deviation 4.71

SECONDARY outcome

Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Population: Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment

The BCS subscale of FACT-B measures additional concerns of breast cancer . Total BCS scores range from 0 to 36, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for BCS is 2-3 points. FACT-B was assessed at baseline (prior to start of Cycle 1 \[Day 1\]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

Outcome measures

Outcome measures
Measure
Paclitaxel Plus Bevacizumab (PB)
n=62 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=56 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy
-0.1 units on a scale
Standard Deviation 5.02
-1.9 units on a scale
Standard Deviation 4.03

SECONDARY outcome

Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Population: Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment

The TOI-B represents the total of the subscales PWB,FWB, and BCS. Total TOI-B scores range from 0 to 92, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for TOI is 5-6 points. FACT-B was assessed at baseline (prior to start of Cycle 1 \[Day 1\]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

Outcome measures

Outcome measures
Measure
Paclitaxel Plus Bevacizumab (PB)
n=60 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=55 Participants
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy
-2.5 units on a scale
Standard Deviation 12.53
-9.1 units on a scale
Standard Deviation 12.68

Adverse Events

Paclitaxel Plus Bevacizumab (PB)

Serious events: 27 serious events
Other events: 93 other events
Deaths: 0 deaths

Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)

Serious events: 36 serious events
Other events: 93 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Paclitaxel Plus Bevacizumab (PB)
n=94 participants at risk
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=93 participants at risk
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Blood and lymphatic system disorders
Anaemia
2.1%
2/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
2.2%
2/93 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Blood and lymphatic system disorders
Febrile neutropenia
2.1%
2/94 • Number of events 3
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
9.7%
9/93 • Number of events 9
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Blood and lymphatic system disorders
Leukopenia
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
3.2%
3/93 • Number of events 3
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
4.3%
4/93 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Blood and lymphatic system disorders
Thrombocytopenia
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Cardiac disorders
Arrhythmia
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Cardiac disorders
Atrial fibrillation
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Cardiac disorders
Cardiac failure congestive
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
3.2%
3/93 • Number of events 3
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Cardiac disorders
Cardiomyopathy
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
2.2%
2/93 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Cardiac disorders
Pericardial effusion
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Cardiac disorders
Tachycardia
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Eye disorders
Macular oedema
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Eye disorders
Vision blurred
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Abdominal pain
3.2%
3/94 • Number of events 3
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Diarrhoea
1.1%
1/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
2.2%
2/93 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Duodenal ulcer
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Duodenitis
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Dysphagia
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Ileus
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Nausea
2.1%
2/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Oesophagitis
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Pancreatitis
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Small intestinal obstruction
1.1%
1/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Vomiting
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Asthenia
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Fatigue
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Generalised oedema
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Oedema peripheral
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Pyrexia
2.1%
2/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
4.3%
4/93 • Number of events 4
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Tenderness
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Visceral oedema
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Hepatobiliary disorders
Hepatic failure
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Hepatobiliary disorders
Hyperbilirubinaemia
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Cellulitis
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
5.4%
5/93 • Number of events 7
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Clostridium difficile colitis
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Diverticulitis
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Gastroenteritis
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Infection
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Pneumonia
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
2.2%
2/93 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Sepsis
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Sinusitis
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Staphylococcal infection
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Upper respiratory tract infection
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Urinary tract infection
3.2%
3/94 • Number of events 4
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Vaginal infection
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Wound infection staphylococcal
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Injury, poisoning and procedural complications
Compression fracture
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Investigations
International normalised ratio
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Metabolism and nutrition disorders
Anorexia
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Metabolism and nutrition disorders
Dehydration
4.3%
4/94 • Number of events 6
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
5.4%
5/93 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Back pain
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
2.1%
2/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Myalgia
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Myopathy toxic
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Hip fracture
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Aphasia
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Cerebrovascular disorder
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Headache
3.2%
3/94 • Number of events 3
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Lethargy
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Somnolence
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Syncope
2.1%
2/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Psychiatric disorders
Confusional state
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Psychiatric disorders
Depression
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Psychiatric disorders
Mental status changes
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Renal and urinary disorders
Haemorrhage urinary tract
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Renal and urinary disorders
Nephrolithiasis
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Renal and urinary disorders
Proteinuria
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Renal and urinary disorders
Renal failure
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Renal and urinary disorders
Renal failure acute
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Cough
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
2.1%
2/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
5.4%
5/93 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Hypoxia
2.1%
2/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
2.2%
2/93 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Lung infiltration
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
2.1%
2/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
2.2%
2/93 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
2.2%
2/93 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Skin and subcutaneous tissue disorders
Skin ulcer
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Skin and subcutaneous tissue disorders
Skin infection
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Surgical and medical procedures
Central venous catheter removal
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Vascular disorders
Deep vein thrombosis
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Vascular disorders
Haemorrhage
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
0.00%
0/93
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Vascular disorders
Hypertension
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Vascular disorders
Thrombosis
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Vascular disorders
Epistaxis
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Vascular disorders
Pulmonary embolism
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
1.1%
1/93 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.

Other adverse events

Other adverse events
Measure
Paclitaxel Plus Bevacizumab (PB)
n=94 participants at risk
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
n=93 participants at risk
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Blood and lymphatic system disorders
Anaemia
19.1%
18/94 • Number of events 38
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
37.6%
35/93 • Number of events 76
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Blood and lymphatic system disorders
Leukopenia
16.0%
15/94 • Number of events 43
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
24.7%
23/93 • Number of events 82
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Blood and lymphatic system disorders
Neutropenia
41.5%
39/94 • Number of events 119
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
69.9%
65/93 • Number of events 169
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Blood and lymphatic system disorders
Thrombocytopenia
7.4%
7/94 • Number of events 13
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
22.6%
21/93 • Number of events 43
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Influenza like illness
2.1%
2/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
5.4%
5/93 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Cardiac disorders
Tachycardia
7.4%
7/94 • Number of events 8
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
6.5%
6/93 • Number of events 6
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Eye disorders
Lacrimation increased
6.4%
6/94 • Number of events 6
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
3.2%
3/93 • Number of events 3
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Abdominal pain
9.6%
9/94 • Number of events 11
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
9.7%
9/93 • Number of events 10
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Constipation
30.9%
29/94 • Number of events 38
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
39.8%
37/93 • Number of events 54
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Diarrhoea
38.3%
36/94 • Number of events 54
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
50.5%
47/93 • Number of events 58
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Dyspepsia
9.6%
9/94 • Number of events 10
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
11.8%
11/93 • Number of events 12
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Haemorrhoids
5.3%
5/94 • Number of events 6
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
6.5%
6/93 • Number of events 6
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Nausea
42.6%
40/94 • Number of events 59
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
62.4%
58/93 • Number of events 85
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Stomatitis
30.9%
29/94 • Number of events 36
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
35.5%
33/93 • Number of events 43
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Gastrointestinal disorders
Vomiting
24.5%
23/94 • Number of events 30
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
32.3%
30/93 • Number of events 38
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Asthenia
12.8%
12/94 • Number of events 13
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
5.4%
5/93 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Chills
5.3%
5/94 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
10.8%
10/93 • Number of events 12
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Fatigue
61.7%
58/94 • Number of events 104
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
79.6%
74/93 • Number of events 129
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Oedema peripheral
20.2%
19/94 • Number of events 20
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
25.8%
24/93 • Number of events 32
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Pain
8.5%
8/94 • Number of events 8
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
12.9%
12/93 • Number of events 13
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
General disorders
Pyrexia
18.1%
17/94 • Number of events 21
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
26.9%
25/93 • Number of events 33
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Infection
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
5.4%
5/93 • Number of events 6
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Sinusitis
14.9%
14/94 • Number of events 21
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
14.0%
13/93 • Number of events 13
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Upper respiratory tract infection
10.6%
10/94 • Number of events 14
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
14.0%
13/93 • Number of events 14
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Infections and infestations
Urinary tract infection
19.1%
18/94 • Number of events 25
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
18.3%
17/93 • Number of events 22
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Investigations
Alanine aminotransferase increased
2.1%
2/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
12.9%
12/93 • Number of events 16
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Investigations
Aspartate aminotransferase increased
4.3%
4/94 • Number of events 4
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
14.0%
13/93 • Number of events 19
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Investigations
Blood alkaline phosphatase increased
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
5.4%
5/93 • Number of events 7
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Investigations
Weight decreased
16.0%
15/94 • Number of events 15
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
17.2%
16/93 • Number of events 22
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Metabolism and nutrition disorders
Anorexia
20.2%
19/94 • Number of events 24
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
21.5%
20/93 • Number of events 28
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Metabolism and nutrition disorders
Decreased appetite
5.3%
5/94 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
3.2%
3/93 • Number of events 3
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Metabolism and nutrition disorders
Dehydration
8.5%
8/94 • Number of events 14
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
10.8%
10/93 • Number of events 14
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Metabolism and nutrition disorders
Hyperglycaemia
4.3%
4/94 • Number of events 13
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
7.5%
7/93 • Number of events 12
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
5.4%
5/93 • Number of events 6
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Metabolism and nutrition disorders
Hypocalcaemia
1.1%
1/94 • Number of events 3
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
7.5%
7/93 • Number of events 9
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Metabolism and nutrition disorders
Hypokalaemia
4.3%
4/94 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
6.5%
6/93 • Number of events 7
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Metabolism and nutrition disorders
Hyponatraemia
3.2%
3/94 • Number of events 4
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
8.6%
8/93 • Number of events 10
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Arthralgia
24.5%
23/94 • Number of events 26
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
21.5%
20/93 • Number of events 23
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Back pain
14.9%
14/94 • Number of events 15
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
19.4%
18/93 • Number of events 21
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Bone pain
8.5%
8/94 • Number of events 9
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
15.1%
14/93 • Number of events 18
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Skin and subcutaneous tissue disorders
Dry skin
5.3%
5/94 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
10.8%
10/93 • Number of events 10
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
6.4%
6/94 • Number of events 7
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
9.7%
9/93 • Number of events 11
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Myalgia
21.3%
20/94 • Number of events 22
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
16.1%
15/93 • Number of events 15
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Musculoskeletal and connective tissue disorders
Pain in extremity
11.7%
11/94 • Number of events 16
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
17.2%
16/93 • Number of events 19
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Dizziness
14.9%
14/94 • Number of events 15
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
10.8%
10/93 • Number of events 10
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Dysgeusia
9.6%
9/94 • Number of events 10
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
12.9%
12/93 • Number of events 13
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Headache
24.5%
23/94 • Number of events 25
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
28.0%
26/93 • Number of events 30
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Neuropathy
8.5%
8/94 • Number of events 9
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
10.8%
10/93 • Number of events 13
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Neuropathy peripheral
14.9%
14/94 • Number of events 19
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
9.7%
9/93 • Number of events 10
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Paraesthesia
5.3%
5/94 • Number of events 6
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
2.2%
2/93 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Nervous system disorders
Peripheral sensory neuropathy
52.1%
49/94 • Number of events 72
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
45.2%
42/93 • Number of events 53
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Psychiatric disorders
Anxiety
16.0%
15/94 • Number of events 17
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
9.7%
9/93 • Number of events 11
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Psychiatric disorders
Confusional state
0.00%
0/94
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
5.4%
5/93 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Psychiatric disorders
Depression
11.7%
11/94 • Number of events 11
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
8.6%
8/93 • Number of events 8
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Psychiatric disorders
Insomnia
13.8%
13/94 • Number of events 16
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
19.4%
18/93 • Number of events 21
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Renal and urinary disorders
Dysuria
7.4%
7/94 • Number of events 7
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
5.4%
5/93 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Renal and urinary disorders
Pollakiuria
5.3%
5/94 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
3.2%
3/93 • Number of events 3
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Renal and urinary disorders
Proteinuria
3.2%
3/94 • Number of events 11
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
8.6%
8/93 • Number of events 11
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Cough
23.4%
22/94 • Number of events 30
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
26.9%
25/93 • Number of events 36
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Dysphonia
1.1%
1/94 • Number of events 1
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
8.6%
8/93 • Number of events 9
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
23.4%
22/94 • Number of events 22
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
26.9%
25/93 • Number of events 29
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
2.1%
2/94 • Number of events 3
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
6.5%
6/93 • Number of events 7
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
4.3%
4/94 • Number of events 4
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
7.5%
7/93 • Number of events 9
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
12.8%
12/94 • Number of events 14
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
10.8%
10/93 • Number of events 11
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
7.4%
7/94 • Number of events 8
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
8.6%
8/93 • Number of events 8
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
2.1%
2/94 • Number of events 2
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
7.5%
7/93 • Number of events 7
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Skin and subcutaneous tissue disorders
Alopecia
43.6%
41/94 • Number of events 42
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
47.3%
44/93 • Number of events 49
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Skin and subcutaneous tissue disorders
Erythema
7.4%
7/94 • Number of events 7
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
7.5%
7/93 • Number of events 10
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Skin and subcutaneous tissue disorders
Nail disorder
18.1%
17/94 • Number of events 25
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
22.6%
21/93 • Number of events 25
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Skin and subcutaneous tissue disorders
Pruritus
4.3%
4/94 • Number of events 4
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
5.4%
5/93 • Number of events 5
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Skin and subcutaneous tissue disorders
Rash
19.1%
18/94 • Number of events 23
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
30.1%
28/93 • Number of events 34
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Vascular disorders
Hot flush
6.4%
6/94 • Number of events 6
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
7.5%
7/93 • Number of events 9
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Vascular disorders
Hypertension
23.4%
22/94 • Number of events 25
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
17.2%
16/93 • Number of events 23
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
Vascular disorders
Epistaxis
43.6%
41/94 • Number of events 51
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
43.0%
40/93 • Number of events 49
Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60