Trial Outcomes & Findings for A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR" (NCT NCT01903993)
NCT ID: NCT01903993
Last Updated: 2019-10-02
Results Overview
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
287 participants
Primary outcome timeframe
From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
Results posted on
2019-10-02
Participant Flow
A total of 527 participants were screened, of whom 287 participants were randomized. 143 participants to the docetaxel arm and 144 participants to the atezolizumab arm. Overall, 10 participants (8 in the docetaxel arm and 2 in the atezolizumab arm) did not receive any study treatment.
Participant milestones
| Measure |
Docetaxel
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
144
|
|
Overall Study
Received Treatment
|
135
|
142
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
143
|
144
|
Reasons for withdrawal
| Measure |
Docetaxel
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|
|
Overall Study
Death
|
118
|
121
|
|
Overall Study
Withdrawal by Subject
|
15
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Study Terminated by Sponsor
|
8
|
14
|
|
Overall Study
Terminated by Sponsor After 31 Aug 2018
|
0
|
2
|
Baseline Characteristics
A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"
Baseline characteristics by cohort
| Measure |
Docetaxel
n=143 Participants
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
n=144 Participants
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
Total
n=287 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)Population: ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
Outcome measures
| Measure |
Docetaxel
n=143 Participants
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
n=144 Participants
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|
|
Overall Survival (OS)
|
9.7 months
Interval 8.6 to 12.0
|
12.6 months
Interval 9.7 to 16.0
|
SECONDARY outcome
Timeframe: Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)Population: ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Docetaxel
n=143 Participants
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
n=144 Participants
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
14.7 percentage of participants
Interval 9.33 to 21.57
|
15.3 percentage of participants
Interval 9.83 to 22.21
|
SECONDARY outcome
Timeframe: From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)Population: ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Docetaxel
n=143 Participants
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
n=144 Participants
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
3.4 months
Interval 2.8 to 4.1
|
2.7 months
Interval 2.0 to 4.1
|
SECONDARY outcome
Timeframe: From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)Population: ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Docetaxel
n=21 Participants
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
n=21 Participants
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|
|
Duration of Response (DOR)
|
7.2 months
Interval 5.6 to 12.5
|
18.6 months
Interval 11.6 to
Upper limit of confidence interval (CI) was not achieved due to low number of participants with event.
|
SECONDARY outcome
Timeframe: From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)Population: ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only
ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l\< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Docetaxel
n=144 Participants
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|
|
ORR (Modified RECIST)
|
16.7 percentage of participants
Interval 10.98 to 23.78
|
—
|
SECONDARY outcome
Timeframe: From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)Population: ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only
PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Docetaxel
n=144 Participants
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|
|
PFS (Modified RECIST)
|
4.2 months
Interval 3.9 to 6.9
|
—
|
SECONDARY outcome
Timeframe: From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)Population: ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. The data was planned to be reported for Atezolizumab arm only.
DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Docetaxel
n=24 Participants
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|
|
DOR (Modified RECIST)
|
14.9 months
Interval 11.6 to
Upper limit of CI was not achieved due to low number of participants with event.
|
—
|
Adverse Events
Docetaxel
Serious events: 46 serious events
Other events: 125 other events
Deaths: 118 deaths
Atezolizumab
Serious events: 53 serious events
Other events: 127 other events
Deaths: 121 deaths
Serious adverse events
| Measure |
Docetaxel
n=135 participants at risk
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
n=142 participants at risk
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Pneumonia
|
2.2%
3/135 • Number of events 3 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
7.0%
10/142 • Number of events 13 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Sepsis
|
2.2%
3/135 • Number of events 5 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Immune system disorders
Contrast Media Allergy
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Thoracic Spinal Stenosis
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Product Issues
Device Dislocation
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
Peripheral embolism
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.74%
1/135 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
Venous stenosis
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Asthenia
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Death
|
1.5%
2/135 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Fatigue
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Pain
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Pyrexia
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
2.1%
3/142 • Number of events 3 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
Delirium
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
1.4%
2/142 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
Urine output decreased
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
1.4%
2/142 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.74%
1/135 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
2/135 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
5.6%
8/142 • Number of events 8 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.2%
3/135 • Number of events 3 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
1.4%
2/142 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
2.8%
4/142 • Number of events 4 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
1.4%
2/142 • Number of events 3 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.4%
6/135 • Number of events 6 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
1.4%
2/142 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.74%
1/135 • Number of events 3 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.2%
7/135 • Number of events 7 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.5%
2/135 • Number of events 3 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
1.4%
2/142 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
1.4%
2/142 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/142 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
Other adverse events
| Measure |
Docetaxel
n=135 participants at risk
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
|
Atezolizumab
n=142 participants at risk
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
3.0%
4/135 • Number of events 4 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
6.3%
9/142 • Number of events 9 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Asthenia
|
16.3%
22/135 • Number of events 28 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.3%
16/142 • Number of events 26 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Chest pain
|
4.4%
6/135 • Number of events 8 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
8.5%
12/142 • Number of events 13 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Fatigue
|
40.7%
55/135 • Number of events 87 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
38.7%
55/142 • Number of events 82 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Oedema peripheral
|
9.6%
13/135 • Number of events 18 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
6.3%
9/142 • Number of events 11 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Pain
|
7.4%
10/135 • Number of events 11 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
4.2%
6/142 • Number of events 7 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Pyrexia
|
11.9%
16/135 • Number of events 19 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
16.2%
23/142 • Number of events 28 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
Insomnia
|
8.1%
11/135 • Number of events 12 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
16.9%
24/142 • Number of events 26 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
Weight decreased
|
8.1%
11/135 • Number of events 11 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
14.1%
20/142 • Number of events 24 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
27/135 • Number of events 38 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
19.7%
28/142 • Number of events 53 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
15/135 • Number of events 23 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
2.1%
3/142 • Number of events 4 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.4%
33/135 • Number of events 40 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
31.7%
45/142 • Number of events 61 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
27/135 • Number of events 32 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
24.6%
35/142 • Number of events 41 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.2%
3/135 • Number of events 3 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
7.7%
11/142 • Number of events 12 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.4%
6/135 • Number of events 10 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.6%
15/142 • Number of events 21 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.5%
2/135 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
7.0%
10/142 • Number of events 14 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
Dizziness
|
8.1%
11/135 • Number of events 12 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
7.0%
10/142 • Number of events 16 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
Headache
|
7.4%
10/135 • Number of events 10 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.6%
15/142 • Number of events 18 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
12.6%
17/135 • Number of events 21 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
2.8%
4/142 • Number of events 7 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.9%
12/135 • Number of events 21 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Eye disorders
Lacrimation increased
|
5.2%
7/135 • Number of events 9 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
23.7%
32/135 • Number of events 34 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
22.5%
32/142 • Number of events 33 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.1%
38/135 • Number of events 51 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
17.6%
25/142 • Number of events 38 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.2%
7/135 • Number of events 7 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
2.8%
4/142 • Number of events 4 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.2%
7/135 • Number of events 8 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
5.6%
8/142 • Number of events 12 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
45/135 • Number of events 64 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
22.5%
32/142 • Number of events 45 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
9/135 • Number of events 9 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
2.1%
3/142 • Number of events 3 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
18/135 • Number of events 20 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
14.1%
20/142 • Number of events 26 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.5%
52/135 • Number of events 57 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
2.1%
3/142 • Number of events 3 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.4%
10/135 • Number of events 10 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
3.5%
5/142 • Number of events 6 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
6.7%
9/135 • Number of events 9 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.70%
1/142 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
6/135 • Number of events 6 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.3%
16/142 • Number of events 26 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.9%
16/135 • Number of events 19 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.6%
15/142 • Number of events 30 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
12/135 • Number of events 16 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
16.2%
23/142 • Number of events 28 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
10/135 • Number of events 11 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
14.8%
21/142 • Number of events 22 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.0%
4/135 • Number of events 5 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
6.3%
9/142 • Number of events 13 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
8/135 • Number of events 8 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
14.1%
20/142 • Number of events 20 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
18/135 • Number of events 24 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
6.3%
9/142 • Number of events 10 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.4%
14/135 • Number of events 19 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
7.0%
10/142 • Number of events 12 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.2%
13/142 • Number of events 14 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.5%
29/135 • Number of events 37 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
35.9%
51/142 • Number of events 60 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.1%
11/135 • Number of events 11 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
4.2%
6/142 • Number of events 8 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.0%
4/135 • Number of events 4 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
6.3%
9/142 • Number of events 12 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.0%
4/135 • Number of events 4 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
6.3%
9/142 • Number of events 15 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
3/135 • Number of events 5 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
8.5%
12/142 • Number of events 17 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Influenza like illness
|
1.5%
2/135 • Number of events 2 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
5.6%
8/142 • Number of events 10 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.4%
6/135 • Number of events 7 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
7.0%
10/142 • Number of events 15 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
Chills
|
3.0%
4/135 • Number of events 4 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
5.6%
8/142 • Number of events 9 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/135 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
5.6%
8/142 • Number of events 16 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.74%
1/135 • Number of events 1 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
7.0%
10/142 • Number of events 21 • From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER