Trial Outcomes & Findings for Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (NCT NCT02000622)
NCT ID: NCT02000622
Last Updated: 2026-02-13
Results Overview
Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.
Results posted on
2026-02-13
Participant Flow
The first patient was enrolled on 27 March 2014 and the last patient on 30 October 2015. Patients were randomized at 125 centres across 19 countries in North America, South America, Europe and Asia.
Screening occurred in 2 parts. Part 1: patients with unknown BRCA status were tested by Myriad. Part 1 screening failures were mostly due to no BRCA1/2 mutation detected. Part 2: patients with a known germline BRCA mutation were screened. 302 patients were randomized.
Participant milestones
| Measure |
Olaparib 300 mg bd
|
Chemotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
205
|
97
|
|
Overall Study
COMPLETED
|
36
|
17
|
|
Overall Study
NOT COMPLETED
|
169
|
80
|
Reasons for withdrawal
| Measure |
Olaparib 300 mg bd
|
Chemotherapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Death
|
159
|
73
|
|
Overall Study
Withdrawn due to site closure
|
1
|
0
|
Baseline Characteristics
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
Baseline characteristics by cohort
| Measure |
Olaparib 300 mg bd
n=205 Participants
|
Chemotherapy
n=97 Participants
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age (years)
|
44 Years
n=41 Participants
|
45 Years
n=1581 Participants
|
44 Years
n=4626 Participants
|
|
Age, Customized
<50
|
138 Participants
n=41 Participants
|
63 Participants
n=1581 Participants
|
201 Participants
n=4626 Participants
|
|
Age, Customized
>=50-<65
|
56 Participants
n=41 Participants
|
30 Participants
n=1581 Participants
|
86 Participants
n=4626 Participants
|
|
Age, Customized
>=65
|
11 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
|
Sex: Female, Male
Female
|
200 Participants
n=41 Participants
|
95 Participants
n=1581 Participants
|
295 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
7 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
66 Participants
n=41 Participants
|
28 Participants
n=1581 Participants
|
94 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=41 Participants
|
63 Participants
n=1581 Participants
|
197 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · BULGARIA
|
4 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · CHINA
|
32 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
41 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · CZECH REPUBLIC
|
11 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
12 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · FRANCE
|
5 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
9 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · HUNGARY
|
10 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
10 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · ITALY
|
17 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
24 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · JAPAN
|
15 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
24 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · KOREA
|
11 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · MEXICO
|
1 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · PERU
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · POLAND
|
10 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · ROMANIA
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · RUSSIAN FEDERATION
|
10 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · SPAIN
|
7 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · SWITZERLAND
|
6 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · TAIWAN
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · TURKEY
|
8 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
14 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · UNITED KINGDOM
|
8 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
12 Participants
n=4626 Participants
|
|
Region of Enrollment
Global · UNITED STATES
|
45 Participants
n=41 Participants
|
19 Participants
n=1581 Participants
|
64 Participants
n=4626 Participants
|
|
Receptor status
ER and/or PgR positive
|
103 Participants
n=41 Participants
|
49 Participants
n=1581 Participants
|
152 Participants
n=4626 Participants
|
|
Receptor status
ER and PgR negative
|
102 Participants
n=41 Participants
|
48 Participants
n=1581 Participants
|
150 Participants
n=4626 Participants
|
|
Received prior chemotherapy for metastatic breast cancer
Yes
|
146 Participants
n=41 Participants
|
69 Participants
n=1581 Participants
|
215 Participants
n=4626 Participants
|
|
Received prior chemotherapy for metastatic breast cancer
No
|
59 Participants
n=41 Participants
|
28 Participants
n=1581 Participants
|
87 Participants
n=4626 Participants
|
|
Received prior platinum for breast cancer
Yes
|
60 Participants
n=41 Participants
|
26 Participants
n=1581 Participants
|
86 Participants
n=4626 Participants
|
|
Received prior platinum for breast cancer
No
|
145 Participants
n=41 Participants
|
71 Participants
n=1581 Participants
|
216 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.Population: Full Analysis Set (FAS) consisting of all randomised patients
Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Olaparib 300 mg bd
n=205 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=97 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
|
7.0 Months
Interval 5.7 to 8.3
|
4.2 Months
Interval 2.8 to 4.3
|
SECONDARY outcome
Timeframe: Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months.Population: Full Analysis Set (FAS) consisting of all randomised patients
Time from randomisation to the earliest of the progression event subsequent to the first objective radiological progression, or death. Second progression may involve any of; objective radiological or symptomatic progression or death. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Symptomatic progression is assessed by investigators based on clinical examination.
Outcome measures
| Measure |
Olaparib 300 mg bd
n=205 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=97 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Time to Second Progression or Death (PFS2)
|
13.2 Months
Interval 10.9 to 15.3
|
9.3 Months
Interval 7.3 to 10.4
|
SECONDARY outcome
Timeframe: Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 30 months.Population: Full Analysis Set (FAS) consisting of all randomised patients
Time from randomisation until death due to any cause.
Outcome measures
| Measure |
Olaparib 300 mg bd
n=205 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=97 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Overall Survival (OS)
|
19.3 Months
Interval 16.7 to 21.8
|
19.6 Months
Interval 14.1 to 24.2
|
SECONDARY outcome
Timeframe: Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.Population: Evaluable For Response (EFR) Analysis Set consisting of all randomised patients with measurable disease at baseline, i.e. at least one measurable target lesion assessed by blinded independent central review (BICR)
Number of responders according to blinded independent central review (BICR) assessment. Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR.
Outcome measures
| Measure |
Olaparib 300 mg bd
n=167 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=66 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
|
100 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: EORTC QLQ-C30 assessments performed at baseline then every ~6 weeks until objective radiological disease progression. Assessed up to a maximum of 30 months.Population: Subset of Full Analysis Set (FAS) consisting of all randomised patients with an evaluable baseline EORTC QLQ-C30 assessment and at least one evaluable post-baseline assessment
Change from baseline in global health status/quality of life (QoL) score assessed using a mixed model for repeated measures (MMRM) analysis, including all post-baseline global health status/QoL scores up to the latest scheduled visit where at least 20 patients on each treatment arm have a score. Global health status/QoL score is on a scale from 0 to 100. A higher score represents an improved health status/QoL.
Outcome measures
| Measure |
Olaparib 300 mg bd
n=191 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=73 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
|
3.9 Score on a scale
Interval 1.5 to 6.3
|
-3.6 Score on a scale
Interval -8.0 to 0.8
|
SECONDARY outcome
Timeframe: Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.Population: Subset of Full Analysis Set (FAS) consisting of all randomised patients who were confirmed as Myriad CDx gBRCAm
Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Assessed in patients with a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).
Outcome measures
| Measure |
Olaparib 300 mg bd
n=202 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=95 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) in Patients Confirmed as Myriad CDx gBRCAm
|
7.4 Months
Interval 5.7 to 8.3
|
4.2 Months
Interval 2.8 to 4.3
|
SECONDARY outcome
Timeframe: Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 40 months.Population: Full Analysis Set (FAS) consisting of all randomised patients
Time from randomisation until death due to any cause.
Outcome measures
| Measure |
Olaparib 300 mg bd
n=205 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=97 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Overall Survival (OS) at Final OS
|
19.3 Months
Interval 17.2 to 21.6
|
17.1 Months
Interval 13.9 to 21.9
|
SECONDARY outcome
Timeframe: Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months.Population: Full Analysis Set (FAS) consisting of all randomised patients
Time from randomisation until death due to any cause.
Outcome measures
| Measure |
Olaparib 300 mg bd
n=205 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=97 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Overall Survival (OS) at Extended OS
|
19.3 Months
Interval 17.2 to 21.6
|
17.1 Months
Interval 13.9 to 21.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months.Population: Full Analysis Set (FAS) consisting of all randomised patients
Time from randomisation to the earliest of first subsequent cancer therapy start date following study treatment discontinuation, or death.
Outcome measures
| Measure |
Olaparib 300 mg bd
n=205 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=97 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Time to First Subsequent Cancer Therapy or Death (TFST)
|
9.4 Months
Interval 8.3 to 10.6
|
4.2 Months
Interval 3.3 to 5.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months.Population: Full Analysis Set (FAS) consisting of all randomised patients
Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death.
Outcome measures
| Measure |
Olaparib 300 mg bd
n=205 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=97 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Time to Second Subsequent Cancer Therapy or Death (TSST)
|
14.3 Months
Interval 12.2 to 15.5
|
10.5 Months
Interval 8.4 to 11.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months.Population: Full Analysis Set (FAS) consisting of all randomised patients
Time from randomisation to the earliest of first subsequent cancer therapy start date following study treatment discontinuation, or death.
Outcome measures
| Measure |
Olaparib 300 mg bd
n=205 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=97 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Time to First Subsequent Cancer Therapy or Death (TFST) at Extended OS
|
9.4 Months
Interval 8.3 to 10.6
|
4.3 Months
Interval 3.4 to 5.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months.Population: Full Analysis Set (FAS) consisting of all randomised patients
Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death.
Outcome measures
| Measure |
Olaparib 300 mg bd
n=205 Participants
Olaparib 300 mg bd tablets
|
Chemotherapy
n=97 Participants
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
|
|---|---|---|
|
Time to Second Subsequent Cancer Therapy or Death (TSST) at Extended OS
|
14.3 Months
Interval 12.3 to 15.7
|
10.5 Months
Interval 8.5 to 11.3
|
Adverse Events
Olaparib 300 mg bd
Serious events: 37 serious events
Other events: 196 other events
Deaths: 159 deaths
Chemotherapy
Serious events: 15 serious events
Other events: 85 other events
Deaths: 73 deaths
Serious adverse events
| Measure |
Olaparib 300 mg bd
n=205 participants at risk
Description (Arm-group)
|
Chemotherapy
n=91 participants at risk
Description (Arm-group)
|
|---|---|---|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
General disorders
Malaise
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
General disorders
Pyrexia
|
1.5%
3/205 • Number of events 3 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Appendicitis
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Gastrointestinal infection
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Pneumonia
|
0.98%
2/205 • Number of events 2 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Pyelonephritis
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Sepsis
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Investigations
Neutrophil count decreased
|
0.98%
2/205 • Number of events 2 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
5/205 • Number of events 7 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
2.2%
2/91 • Number of events 2 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
2.2%
2/91 • Number of events 2 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Cardiac disorders
Atrial fibrillation
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Ear and labyrinth disorders
Vertigo
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Investigations
Platelet count decreased
|
0.98%
2/205 • Number of events 4 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 2 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Nervous system disorders
Central nervous system lesion
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Nervous system disorders
Epilepsy
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Nervous system disorders
Headache
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Nervous system disorders
Intracranial pressure increased
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Nervous system disorders
Seizure
|
0.98%
2/205 • Number of events 5 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
4/205 • Number of events 4 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.49%
1/205 • Number of events 2 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Vascular disorders
Aortic aneurysm
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Vascular disorders
Embolism
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
0.00%
0/91 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/205 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
Other adverse events
| Measure |
Olaparib 300 mg bd
n=205 participants at risk
Description (Arm-group)
|
Chemotherapy
n=91 participants at risk
Description (Arm-group)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
37.1%
76/205 • Number of events 129 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
23.1%
21/91 • Number of events 29 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.2%
23/205 • Number of events 55 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
9.9%
9/91 • Number of events 40 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.8%
14/205 • Number of events 30 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
1.1%
1/91 • Number of events 2 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.0%
37/205 • Number of events 89 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
29.7%
27/91 • Number of events 78 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.3%
13/205 • Number of events 20 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
5.5%
5/91 • Number of events 5 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
7/205 • Number of events 7 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
5.5%
5/91 • Number of events 6 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
14/205 • Number of events 16 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
6.6%
6/91 • Number of events 7 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.3%
15/205 • Number of events 16 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
5.5%
5/91 • Number of events 5 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Constipation
|
12.7%
26/205 • Number of events 30 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
13.2%
12/91 • Number of events 13 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Diarrhoea
|
20.5%
42/205 • Number of events 68 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
20.9%
19/91 • Number of events 29 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
17/205 • Number of events 20 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
4.4%
4/91 • Number of events 4 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Nausea
|
58.0%
119/205 • Number of events 175 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
34.1%
31/91 • Number of events 40 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Stomatitis
|
7.8%
16/205 • Number of events 23 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
11.0%
10/91 • Number of events 10 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Gastrointestinal disorders
Vomiting
|
32.2%
66/205 • Number of events 127 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
14.3%
13/91 • Number of events 18 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
General disorders
Asthenia
|
9.3%
19/205 • Number of events 28 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
13.2%
12/91 • Number of events 15 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
General disorders
Fatigue
|
29.8%
61/205 • Number of events 80 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
24.2%
22/91 • Number of events 23 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
General disorders
Mucosal inflammation
|
2.4%
5/205 • Number of events 5 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
6.6%
6/91 • Number of events 7 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
General disorders
Pyrexia
|
13.2%
27/205 • Number of events 35 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
17.6%
16/91 • Number of events 20 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Influenza
|
6.8%
14/205 • Number of events 15 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
4.4%
4/91 • Number of events 4 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
17/205 • Number of events 26 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
3.3%
3/91 • Number of events 5 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Upper respiratory tract infection
|
13.2%
27/205 • Number of events 40 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
9.9%
9/91 • Number of events 16 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Infections and infestations
Urinary tract infection
|
6.3%
13/205 • Number of events 14 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
3.3%
3/91 • Number of events 3 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Investigations
Alanine aminotransferase increased
|
11.7%
24/205 • Number of events 39 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
17.6%
16/91 • Number of events 19 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Investigations
Aspartate aminotransferase increased
|
9.8%
20/205 • Number of events 29 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
16.5%
15/91 • Number of events 19 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.3%
13/205 • Number of events 14 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
5.5%
5/91 • Number of events 5 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Investigations
Neutrophil count decreased
|
10.2%
21/205 • Number of events 49 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
18.7%
17/91 • Number of events 43 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Investigations
Platelet count decreased
|
4.9%
10/205 • Number of events 19 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
6.6%
6/91 • Number of events 10 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Investigations
White blood cell count decreased
|
16.1%
33/205 • Number of events 75 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
20.9%
19/91 • Number of events 40 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.1%
35/205 • Number of events 41 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
12.1%
11/91 • Number of events 14 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.7%
22/205 • Number of events 27 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
9.9%
9/91 • Number of events 9 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.1%
29/205 • Number of events 32 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
8.8%
8/91 • Number of events 9 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.4%
11/205 • Number of events 11 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
5.5%
5/91 • Number of events 5 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.3%
13/205 • Number of events 13 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
4.4%
4/91 • Number of events 4 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.9%
8/205 • Number of events 8 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
9.9%
9/91 • Number of events 10 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
15/205 • Number of events 19 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
3.3%
3/91 • Number of events 3 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Nervous system disorders
Dizziness
|
8.8%
18/205 • Number of events 18 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
7.7%
7/91 • Number of events 8 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Nervous system disorders
Dysgeusia
|
8.3%
17/205 • Number of events 22 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
6.6%
6/91 • Number of events 6 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Nervous system disorders
Headache
|
20.0%
41/205 • Number of events 51 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
15.4%
14/91 • Number of events 15 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.5%
3/205 • Number of events 3 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
9.9%
9/91 • Number of events 10 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Psychiatric disorders
Insomnia
|
6.3%
13/205 • Number of events 14 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
7.7%
7/91 • Number of events 8 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.1%
35/205 • Number of events 40 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
6.6%
6/91 • Number of events 7 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.3%
15/205 • Number of events 19 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
9.9%
9/91 • Number of events 10 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
7/205 • Number of events 8 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
13.2%
12/91 • Number of events 13 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.49%
1/205 • Number of events 1 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
20.9%
19/91 • Number of events 25 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
6/205 • Number of events 6 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
5.5%
5/91 • Number of events 6 • Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60