Trial Outcomes & Findings for An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma (NCT NCT00738582)
NCT ID: NCT00738582
Last Updated: 2022-09-22
Results Overview
Number of participants with PFS responders and non-responders at Month 6 was reported. PFS was defined as the time from the date of the first dose of amatuximab to the date of disease progression or death due to any cause, as determined by independent radiologist based on the modified Response Evaluation Criteria in Solid Tumors (RECIST) utilizing the total tumor measurement (performed by computerized tomography (CT)/magnetic resonance imaging (MRI)) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. A "response", in terms of PFS, was defined to be at least a 6-month stabilization of disease. Progressive disease (PD) as measured by Modified RECIST was defined as an increase of at least 20 percent (%) in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Month 6
Results posted on
2022-09-22
Participant Flow
Participant milestones
| Measure |
Amatuximab/Pemetrexed/Cisplatin
Participants received amatuximab 5 milligram per kilogram (mg/kg), Intravenous (IV) infusion on Days 1 and 8 with pemetrexed 500 milligram per meter square (mg/m\^2), IV infusion on Day 1 and cisplatin 75 mg/m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy (Cycle length is 21 days).
|
Amatuximab
Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles) (Cycle length is 21 days).
|
|---|---|---|
|
Combination Therapy
STARTED
|
89
|
0
|
|
Combination Therapy
COMPLETED
|
56
|
0
|
|
Combination Therapy
NOT COMPLETED
|
33
|
0
|
|
Maintenance Therapy
STARTED
|
0
|
56
|
|
Maintenance Therapy
COMPLETED
|
0
|
0
|
|
Maintenance Therapy
NOT COMPLETED
|
0
|
56
|
Reasons for withdrawal
| Measure |
Amatuximab/Pemetrexed/Cisplatin
Participants received amatuximab 5 milligram per kilogram (mg/kg), Intravenous (IV) infusion on Days 1 and 8 with pemetrexed 500 milligram per meter square (mg/m\^2), IV infusion on Day 1 and cisplatin 75 mg/m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy (Cycle length is 21 days).
|
Amatuximab
Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles) (Cycle length is 21 days).
|
|---|---|---|
|
Combination Therapy
Completed Combination Therapy
|
1
|
0
|
|
Combination Therapy
Physician Decision
|
1
|
0
|
|
Combination Therapy
Toxicity to Chemotherapy
|
1
|
0
|
|
Combination Therapy
Other
|
5
|
0
|
|
Combination Therapy
Adverse Event
|
16
|
0
|
|
Combination Therapy
Progressive Disease
|
9
|
0
|
|
Maintenance Therapy
Other
|
0
|
2
|
|
Maintenance Therapy
Adverse Event
|
0
|
6
|
|
Maintenance Therapy
Progressive Disease
|
0
|
47
|
|
Maintenance Therapy
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
Baseline characteristics by cohort
| Measure |
All Participants
n=89 Participants
Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
|---|---|
|
Age, Continuous
|
67 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Primary Efficacy Population: all participants who received at least 1 dose of amatuximab and met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab). Here, number of participants analyzed are first 77 enrolled participants.
Number of participants with PFS responders and non-responders at Month 6 was reported. PFS was defined as the time from the date of the first dose of amatuximab to the date of disease progression or death due to any cause, as determined by independent radiologist based on the modified Response Evaluation Criteria in Solid Tumors (RECIST) utilizing the total tumor measurement (performed by computerized tomography (CT)/magnetic resonance imaging (MRI)) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. A "response", in terms of PFS, was defined to be at least a 6-month stabilization of disease. Progressive disease (PD) as measured by Modified RECIST was defined as an increase of at least 20 percent (%) in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
Outcome measures
| Measure |
All Participants
n=77 Participants
Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
Amatuximab
Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
|---|---|---|
|
Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6
PFS Responders
|
26 Participants
|
—
|
|
Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6
PFS non-responders
|
51 Participants
|
—
|
SECONDARY outcome
Timeframe: From the date of first dose until evidence of CR or PR, up to approximately 5 yearsPopulation: Primary Efficacy Population: all participants who received at least 1 dose of amatuximab and met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab).
ORR, defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) as determined by independent radiologist based on the modified RECIST utilizing the total tumor measurement (performed by CT/ MRI) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. Tumor assessments performed up to the initiation of further anticancer therapy were considered. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement. A confirmed response required a repeat observation on two occasions 4 weeks apart. ORR = CR + PR.
Outcome measures
| Measure |
All Participants
n=84 Participants
Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
Amatuximab
Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
|---|---|---|
|
Overall Response Rate (ORR)
|
34.5 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 yearsPopulation: Primary Efficacy Population: all participants who received at least 1 dose of amatuximab, met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab). Here, number of participants analysed included responders (CR or PR).
DR was derived for those participants who achieved a PFS Response and had an objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression or death \[as determined by independent radiologist based on the modified RECIST utilizing the total tumor measurement (performed by CT/ MRI) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement\]. Tumor assessments performed up to the initiation of further anticancer therapy were considered. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement. PD as measured by Modified RECIST was defined as an increase of at least 20% in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
Outcome measures
| Measure |
All Participants
n=29 Participants
Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
Amatuximab
Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
|---|---|---|
|
Duration of Response (DR)
|
9.2 Months
Interval 6.0 to 16.2
|
—
|
SECONDARY outcome
Timeframe: From the date of the first dose to first documentation of objective response, up to approximately 5 yearsPopulation: Primary Efficacy Population: all participants who received at least 1 dose of amatuximab and met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab). Here, number of participants analysed included responders (CR or PR).
TTR was derived for those participants with objective evidence of CR or PR. TTR was defined as the time from the date of the first dose of amatuximab to first documentation of objective tumor response. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement.
Outcome measures
| Measure |
All Participants
n=29 Participants
Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
Amatuximab
Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
|---|---|---|
|
Time to Tumor Response (TTR)
|
2.3 Months
Interval 2.1 to 3.8
|
—
|
SECONDARY outcome
Timeframe: From the date of first dose to the date of death, up to approximately 5 yearsPopulation: Safety population consisted of all participants who received at least 1 dose of amatuximab.
OS was defined as the time from the date of the first dose of amatuximab to the date of death.
Outcome measures
| Measure |
All Participants
n=89 Participants
Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
Amatuximab
Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
|---|---|---|
|
Overall Survival (OS)
|
14.8 Months
Interval 12.4 to 18.8
|
—
|
SECONDARY outcome
Timeframe: From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 yearsPopulation: Primary Efficacy Population: all participants who received at least 1 dose of amatuximab and met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab).
Overall PFS was defined as the time from the date of first dose of amatuximab to the date of disease progression or death due to any cause. In the absence of confirmation of death, the survival time was censored at the date of the last follow-up contact. Tumor assessments performed up to the initiation of further anticancer therapy were considered. PD as measured by Modified RECIST was defined as an increase of at least 20% in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
Outcome measures
| Measure |
All Participants
n=84 Participants
Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
Amatuximab
Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
|---|---|---|
|
Overall Progression Free Survival
|
6.3 Months
Interval 6.0 to 7.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 yearsPopulation: Safety population included all participants who received at least 1 dose of amatuximab.
An adverse event (AE) was any untoward medical occurrence (example; any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study until the end of study visit. TEAEs were defined as an AE that developed or worsened in severity during the on-treatment period (from first dose of amatuximab to 30 days after last dose of amatuximab). SAE was defined as any adverse event (appearance of \[or worsening of any pre-existing\]) undesirable sign, symptom or medical conditions which is fatal or life-threatening or results in persistent or significant disability/incapacity or constitutes a congenital anomaly/birth defect or requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.
Outcome measures
| Measure |
All Participants
n=89 Participants
Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
Amatuximab
n=56 Participants
Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab
Participants with at least 1 TEAE
|
89 Participants
|
52 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab
Participants with at least 1 SAE
|
38 Participants
|
15 Participants
|
Adverse Events
Amatuximab/Pemetrexed/Cisplatin
Serious events: 38 serious events
Other events: 89 other events
Deaths: 4 deaths
Amatuximab
Serious events: 15 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amatuximab/Pemetrexed/Cisplatin
n=89 participants at risk
Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy (Cycle length is 21 days).
|
Amatuximab
n=56 participants at risk
Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Ileus paralytic
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Renal failure acute
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Renal impairment
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Pneumonia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Device related infection
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Infectious peritonitis
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Neutropenic sepsis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Pyopneumothorax
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Urosepsis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Fatigue
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Non-cardiac Chest Pain
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Pyrexia
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Asthenia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Chills
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
7.1%
4/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Infusion
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Atrial Fibrillation
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Cardio-respiratory Arrest
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Pericarditis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Tachyarrhythmia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Cystitis Radiation
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Seroma
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Immune system disorders
Hypersensitivity
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Immune system disorders
Drug Hypersensitivity
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Embolism
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Hypertension
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Peripheral Embolism
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Thrombosis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
C-reactive Protein Increased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Neutrophil Count Decreased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Platelet Count Decreased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
White Blood Cell Count Decreased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Syncope
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Reproductive system and breast disorders
Prostatitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
Other adverse events
| Measure |
Amatuximab/Pemetrexed/Cisplatin
n=89 participants at risk
Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy (Cycle length is 21 days).
|
Amatuximab
n=56 participants at risk
Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
10.7%
6/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Plantar Fascitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Atrophy
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Lacrimation Increased
|
10.1%
9/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Vision Blurred
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Conjunctivitis
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Dry Eye
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Diplopia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Erythema Of Eyelid
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Eye Irritation
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Eye Pruritus
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Eye Swelling
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Eyelid Oedema
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Lacrimal Disorder
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Periorbital Oedema
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Scleral Haemorrhage
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Visual Impairement
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Eye disorders
Vitreous Floaters
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Anal Fissure
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Anorectal Discomfort
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Bowel Movement Irregularity
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Gingivitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Glossitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Glossodynia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Ileus Paralytic
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Inguinal Hernia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Odynophagia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Oesophagitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Proctalgia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Retching
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Tongue Coated
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Oesophageal Pain
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Oedema Mouth
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Nausea
|
70.8%
63/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
25.0%
14/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Constipation
|
31.5%
28/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
7.1%
4/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Vomiting
|
31.5%
28/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
16.1%
9/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
28.1%
25/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
7.1%
4/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Stomatitis
|
13.5%
12/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
12.4%
11/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
8.9%
5/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
10.1%
9/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
7.9%
7/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
5/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Dry Mouth
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Gastrointestinal disorders
Eructation
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Fatigue
|
58.4%
52/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
19.6%
11/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Asthenia
|
18.0%
16/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
10.7%
6/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Non-Cardiac Chest Pain
|
18.0%
16/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
23.2%
13/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Oedema Peripheral
|
16.9%
15/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
12.5%
7/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Chills
|
14.6%
13/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
8.9%
5/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Pyrexia
|
14.6%
13/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Catheter Site Pain
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Chest Discomfort
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Chest Pain
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Pain
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
General Physical Health Deterioration
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Oedema
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Catheter Site Swelling
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Extravasation
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Face Oedema
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Feeling Hot
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Feeling Jittery
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Injection Site Reaction
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Medical Device Complication
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Pre-Existing Condition Improved
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Catheter Site Haemorrhage
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
General Symptoms
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
General disorders
Influenza Like Illness
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
44.9%
40/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
17.9%
10/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.2%
10/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.0%
8/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
6/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
6/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.6%
5/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Fluid Retention
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Gout
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Tumour Lysis Syndrome
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Dysgeusia
|
19.1%
17/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Dizziness
|
16.9%
15/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Headache
|
12.4%
11/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
8.9%
5/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Paraesthesia
|
6.7%
6/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
8.9%
5/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Neuropathy Peripheral
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
17.9%
10/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Polyneuropathy
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Somnolence
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Tremor
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Ageusia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Aphasia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Balance Disorder
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Dysaethesia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Epilepsy
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Lethargy
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Parosmia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Phrenic Nerve Paralysis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Post Herpetic Neuralgia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Restless Legs Syndrome
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Sciatica
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Sinus Headache
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Syncope
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Vascular Headache
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Dystonia
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
29.2%
26/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
29.2%
26/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.2%
10/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
5/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.0%
16/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
32.1%
18/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.6%
13/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
17.9%
10/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
12.4%
11/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epitaxis
|
7.9%
7/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
5.6%
5/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
8.9%
5/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
7.1%
4/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat Tightness
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.7%
14/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.4%
11/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.1%
9/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.9%
7/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
5.6%
5/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Scar Pain
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Penile Ulceration
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Facial Wasting
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Palmar Erythema
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Nodule
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Nasopharyngitis
|
9.0%
8/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
12.5%
7/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Candidiasis
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Urinary Tract Infection
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
7.1%
4/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Cellulitis
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Pneumonia
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Respiratory Tract Infection
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Rhinitis
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Bronchitis
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Sinusitis
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Bronchopneumonia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Device Related Infection
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Eye Infection
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Gastroenteritis Viral
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Herpes Virus Infection
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Herpes Zoster Opthalmic
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Neutropenic Sepsis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Oral Candidiasis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Oral Herpes
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Otitis Media
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Pharyngitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Pneumonia Primary Atypical
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Pyopneumothorax
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Tinea Pedis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Urosepsis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Influenza
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Appendictis
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Febrile Infection
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Infectious Peritonitis
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Lung Infection
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Weight Decreased
|
19.1%
17/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Blood Creatinine Increased
|
15.7%
14/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Breathe Sounds Abnormal
|
6.7%
6/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Haemoglobin Decreased
|
6.7%
6/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
White Blood Cell Count Decreased
|
5.6%
5/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Platelet Count Decreased
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Weight Increased
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Blood Urea Increased
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
C-Reactive Protein Increased
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Neutrophil Count Decreased
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Percussion Test Abnormal
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Blood Albumin Decreased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Blood Cholesterol Increased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Blood Glucose Increased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Blood Phosphorus Decreased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Blood Potassium Decreased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Blood Sodium Decreased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Cardiac Murmur
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Glomerular Filteration Rate Decreased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Heart Rate Irregular
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
International Normalised Ratio Increased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Occult Blood Positive
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
White Blood Cell Count Increased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Anion Gap Increased
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Blood Bicarbonate Increased
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Blood Lactate Dehyrogenase Increased
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Gamma Glutamyl Transferase Increased
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Investigations
Red Blood Cell Count Decreased
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.6%
13/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
12.5%
7/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
6/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
5.6%
5/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
7.1%
4/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.6%
5/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
8.9%
5/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscoskeletal Pain
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
10.7%
6/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
5.4%
3/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
12.4%
11/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
7.9%
7/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Ear and labyrinth disorders
Deafness
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Ear and labyrinth disorders
Deafness Bilateral
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Ear and labyrinth disorders
Dysacusis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Ear and labyrinth disorders
Ear Pain
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Ear and labyrinth disorders
Ototoxicity
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Hypertension
|
6.7%
6/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
8.9%
5/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Hypotension
|
5.6%
5/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Flushing
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Embolism
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Hot Flush
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Pallor
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Peripheral Coldness
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Peripheral Embolism
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Thrombosis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Varicose Vein
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Thrombophlebitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Vascular disorders
Embolism Venous
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Psychiatric disorders
Insomnia
|
7.9%
7/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Psychiatric disorders
Depression
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Psychiatric disorders
Restlessness
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Psychiatric disorders
Sleep Disorder
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Psychiatric disorders
Depressed Mood
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Psychiatric disorders
Agitation
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Psychiatric disorders
Bulimia Nervosa
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Psychiatric disorders
Confusion State
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Psychiatric disorders
Panic Attack
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Tachycardia
|
6.7%
6/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Atrial Fibrillation
|
5.6%
5/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Palpitations
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Bradycardia
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Tachyarrhythmia
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Angina Pectoris
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Cyanosis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Pericardial Effusion
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Pericarditis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Sinus Tachycardia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
7.9%
7/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.2%
2/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Eye Injury
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Seroma
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Cystitis Radiation
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Radiation Oesophagitis
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Immune system disorders
Hypersensitivity
|
12.4%
11/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
3.6%
2/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Immune system disorders
Drug Hypersensitivity
|
3.4%
3/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Glycosuria
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Ketonuria
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Micturition Urgency
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Nocturia
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Pollakiuria
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Polyuria
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Renal Colic
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Renal Failure Chronic
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Renal Impairment
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Renal Pain
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Urine Flow Decreased
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Pelvic-Ureteric Obstruction
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
4.5%
4/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Skin
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Thyroid Gland
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Reproductive system and breast disorders
Balanitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Reproductive system and breast disorders
Breast Pain
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Reproductive system and breast disorders
Epidifymitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Reproductive system and breast disorders
Genital Burning Sensation
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Reproductive system and breast disorders
Genital Pain
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Reproductive system and breast disorders
Prostatitis
|
1.1%
1/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
0.00%
0/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Reproductive system and breast disorders
Breast Swelling
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Surgical and medical procedures
Colectomy
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.00%
0/89 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
1.8%
1/56 • From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER