Trial Outcomes & Findings for Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment. (NCT NCT01750281)
NCT ID: NCT01750281
Last Updated: 2023-10-24
Results Overview
Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): \>= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
212 participants
Primary outcome timeframe
Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)
Results posted on
2023-10-24
Participant Flow
Initially the study protocol allowed patients with KRASm (KRAS mutation positive), KRAS NMD (No mutation detected) and KRAS mutation status unknown. Recruitment was put on hold after the 77th patient was randomised in September 2013, to allow a protocol amendment to include only patients with centrally confirmed KRAS NMD NSCLC to be enrolled.
The Protocol Section "Enrolment Number" of 466 includes 1 patient who was pre-screened twice. Of the 465 unique "pre-screened" patients, 337 gave informed consent and of these, 212 were randomised. 211 received at least 1 dose of treatment and were included in the safety analysis set. Patients received selumetinib (AZD6244; ARRY-142886) or Placebo.
Participant milestones
| Measure |
Placebo + Docetaxel 75 mg/m^2
Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 60 mg/m^2
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 75 mg/m^2
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
85
|
84
|
|
Overall Study
Received Treatment
|
43
|
84
|
84
|
|
Overall Study
Did Not Receive Treatment
|
0
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
85
|
84
|
Reasons for withdrawal
| Measure |
Placebo + Docetaxel 75 mg/m^2
Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 60 mg/m^2
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 75 mg/m^2
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
|---|---|---|---|
|
Overall Study
Discontinued Selumetinib/Placebo
|
37
|
77
|
75
|
|
Overall Study
Ongoing Selumetinib/Pbo at data cut-off
|
6
|
7
|
9
|
|
Overall Study
Did not receive treatment
|
0
|
1
|
0
|
Baseline Characteristics
Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.
Baseline characteristics by cohort
| Measure |
Placebo + Docetaxel 75 mg/m^2
n=43 Participants
Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 60 mg/m^2
n=85 Participants
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 75 mg/m^2
n=84 Participants
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.6 Years
STANDARD_DEVIATION 7.75 • n=5 Participants
|
62.4 Years
STANDARD_DEVIATION 8.53 • n=7 Participants
|
60.4 Years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
61.8 Years
STANDARD_DEVIATION 8.77 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
199 Participants
n=4 Participants
|
|
KRAS Mutation Status at Baseline
KRAS no mutation detected (NMD)
|
30 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
KRAS Mutation Status at Baseline
KRAS mutation positive
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
KRAS Mutation Status at Baseline
KRAS mutation unknown
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)Population: Full Analysis Set (All randomised patients). Progression events that do not occur within 14 weeks of the last evaluable assessement are censored and therefore excluded.
Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): \>= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.
Outcome measures
| Measure |
Placebo + Docetaxel 75 mg/m^2
n=36 Participants
Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 60 mg/m^2
n=75 Participants
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 75 mg/m^2
n=69 Participants
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
4.3 Months
Interval 1.4 to 5.6
|
3.0 Months
Interval 1.4 to 5.4
|
4.2 Months
Interval 1.6 to 6.9
|
SECONDARY outcome
Timeframe: Following progression, survival status was collected every 8 weeks until death, withdrawal of consent, or end of study, whichever occurred first, up to 29 months (at the time of the analysis)Population: Full Analysis Set (All randomised patients)
The time from randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive
Outcome measures
| Measure |
Placebo + Docetaxel 75 mg/m^2
n=43 Participants
Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 60 mg/m^2
n=85 Participants
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 75 mg/m^2
n=84 Participants
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
|---|---|---|---|
|
Overall Survival (OS)
|
11.5 Months
Interval 4.6 to 28.0
|
5.7 Months
Interval 3.1 to 12.4
|
7.7 Months
Interval 3.8 to 19.5
|
Adverse Events
Placebo + Docetaxel 75 mg/m^2
Serious events: 16 serious events
Other events: 38 other events
Deaths: 0 deaths
Selumetinib 75 mg BD + Docetaxel 60 mg/m^2
Serious events: 40 serious events
Other events: 80 other events
Deaths: 0 deaths
Selumetinib 75 mg BD + Docetaxel 75 mg/m^2
Serious events: 38 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Docetaxel 75 mg/m^2
n=43 participants at risk
Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 60 mg/m^2
n=84 participants at risk
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 75 mg/m^2
n=84 participants at risk
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.0%
3/43 • Number of events 3
|
1.2%
1/84 • Number of events 1
|
4.8%
4/84 • Number of events 4
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Cardiac disorders
Chronic right ventricular failure
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Cardiac disorders
Left ventricular failure
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine perforation
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 3
|
|
General disorders
Asthenia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
General disorders
Fatigue
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
General disorders
Generalised oedema
|
0.00%
0/43
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
General disorders
Performance status decreased
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
General disorders
Pyrexia
|
0.00%
0/43
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Hepatobiliary disorders
Hepatocellular injury
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Infections and infestations
Cellulitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Erysipelas
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Infection
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Infections and infestations
Lung infection
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43 • Number of events 1
|
11.9%
10/84 • Number of events 13
|
4.8%
4/84 • Number of events 4
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
4.8%
4/84 • Number of events 4
|
|
Infections and infestations
Septic shock
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Chemical peritonitis
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Investigations
Blood creatinine increased
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Investigations
Blood urea increased
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Seizure
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/43 • Number of events 1
|
4.8%
4/84 • Number of events 5
|
4.8%
4/84 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Vascular disorders
Hypotension
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
Other adverse events
| Measure |
Placebo + Docetaxel 75 mg/m^2
n=43 participants at risk
Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 60 mg/m^2
n=84 participants at risk
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
Selumetinib 75 mg BD + Docetaxel 75 mg/m^2
n=84 participants at risk
Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
|
|---|---|---|---|
|
General disorders
Oedema
|
0.00%
0/43
|
0.00%
0/84
|
4.8%
4/84 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/43 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
2.4%
2/84 • Number of events 3
|
|
Investigations
Weight decreased
|
9.3%
4/43 • Number of events 4
|
3.6%
3/84 • Number of events 3
|
7.1%
6/84 • Number of events 6
|
|
Investigations
Weight increased
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Metabolism and nutrition disorders
Central obesity
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.3%
10/43 • Number of events 10
|
25.0%
21/84 • Number of events 21
|
21.4%
18/84 • Number of events 20
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1
|
4.8%
4/84 • Number of events 4
|
4.8%
4/84 • Number of events 4
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/43
|
1.2%
1/84 • Number of events 2
|
0.00%
0/84
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.7%
2/43 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/43
|
0.00%
0/84
|
2.4%
2/84 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.7%
2/43 • Number of events 3
|
3.6%
3/84 • Number of events 3
|
2.4%
2/84 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.3%
1/43 • Number of events 1
|
6.0%
5/84 • Number of events 5
|
2.4%
2/84 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.0%
3/43 • Number of events 3
|
3.6%
3/84 • Number of events 4
|
2.4%
2/84 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
4.8%
4/84 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Metabolism and nutrition disorders
Vitamin K deficiency
|
0.00%
0/43
|
2.4%
2/84 • Number of events 2
|
0.00%
0/84
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
2/43 • Number of events 2
|
7.1%
6/84 • Number of events 7
|
4.8%
4/84 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
4/43 • Number of events 4
|
3.6%
3/84 • Number of events 3
|
8.3%
7/84 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.7%
2/43 • Number of events 2
|
0.00%
0/84
|
3.6%
3/84 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.7%
2/43 • Number of events 2
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.3%
1/43 • Number of events 1
|
4.8%
4/84 • Number of events 7
|
3.6%
3/84 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.3%
4/43 • Number of events 4
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.6%
5/43 • Number of events 5
|
7.1%
6/84 • Number of events 6
|
10.7%
9/84 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
4.8%
4/84 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.0%
6/43 • Number of events 7
|
4.8%
4/84 • Number of events 5
|
2.4%
2/84 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/43
|
4.8%
4/84 • Number of events 4
|
2.4%
2/84 • Number of events 2
|
|
Nervous system disorders
Ageusia
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Nervous system disorders
Amnesia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Ataxia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Dizziness
|
16.3%
7/43 • Number of events 7
|
6.0%
5/84 • Number of events 5
|
6.0%
5/84 • Number of events 5
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
7.0%
3/43 • Number of events 3
|
7.1%
6/84 • Number of events 6
|
9.5%
8/84 • Number of events 8
|
|
Nervous system disorders
Head discomfort
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Nervous system disorders
Headache
|
11.6%
5/43 • Number of events 5
|
7.1%
6/84 • Number of events 6
|
3.6%
3/84 • Number of events 3
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Hypoaesthesia
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Lethargy
|
0.00%
0/43
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/43
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Nervous system disorders
Neuropathy peripheral
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
4.8%
4/84 • Number of events 4
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/43
|
3.6%
3/84 • Number of events 4
|
3.6%
3/84 • Number of events 3
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.7%
2/43 • Number of events 2
|
4.8%
4/84 • Number of events 4
|
4.8%
4/84 • Number of events 4
|
|
Nervous system disorders
Polyneuropathy
|
2.3%
1/43 • Number of events 1
|
4.8%
4/84 • Number of events 4
|
3.6%
3/84 • Number of events 4
|
|
Nervous system disorders
Somnolence
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/43
|
2.4%
2/84 • Number of events 2
|
0.00%
0/84
|
|
Nervous system disorders
Tremor
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/43
|
3.6%
3/84 • Number of events 3
|
1.2%
1/84 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Psychiatric disorders
Disorientation
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Psychiatric disorders
Insomnia
|
4.7%
2/43 • Number of events 2
|
4.8%
4/84 • Number of events 5
|
3.6%
3/84 • Number of events 3
|
|
Psychiatric disorders
Sleep disorder
|
4.7%
2/43 • Number of events 3
|
0.00%
0/84
|
1.2%
1/84 • Number of events 2
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 2
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
6.0%
5/84 • Number of events 6
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Renal and urinary disorders
Renal cyst
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
|
Renal and urinary disorders
Renal impairment
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 2
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 2
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.7%
2/43 • Number of events 2
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
1/43 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.6%
8/43 • Number of events 8
|
8.3%
7/84 • Number of events 7
|
11.9%
10/84 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/43
|
2.4%
2/84 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.3%
4/43 • Number of events 4
|
14.3%
12/84 • Number of events 12
|
16.7%
14/84 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.7%
2/43 • Number of events 2
|
3.6%
3/84 • Number of events 3
|
4.8%
4/84 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.7%
2/43 • Number of events 3
|
7.1%
6/84 • Number of events 6
|
9.5%
8/84 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.7%
2/43 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
8.3%
7/84 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/43
|
3.6%
3/84 • Number of events 3
|
6.0%
5/84 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/43 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
3.6%
3/84 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/43
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.3%
1/43 • Number of events 2
|
0.00%
0/84
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.6%
8/43 • Number of events 8
|
13.1%
11/84 • Number of events 11
|
17.9%
15/84 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/43
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.3%
1/43 • Number of events 1
|
10.7%
9/84 • Number of events 18
|
8.3%
7/84 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.7%
2/43 • Number of events 2
|
10.7%
9/84 • Number of events 10
|
19.0%
16/84 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.3%
1/43 • Number of events 1
|
4.8%
4/84 • Number of events 5
|
6.0%
5/84 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/43
|
2.4%
2/84 • Number of events 2
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.7%
2/43 • Number of events 2
|
3.6%
3/84 • Number of events 3
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail growth abnormal
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/43
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/43
|
2.4%
2/84 • Number of events 2
|
2.4%
2/84 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/43
|
4.8%
4/84 • Number of events 5
|
4.8%
4/84 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.9%
9/43 • Number of events 10
|
27.4%
23/84 • Number of events 26
|
34.5%
29/84 • Number of events 44
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/43
|
2.4%
2/84 • Number of events 3
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/43
|
0.00%
0/84
|
3.6%
3/84 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/43
|
2.4%
2/84 • Number of events 2
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/43
|
1.2%
1/84 • Number of events 2
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Vascular disorders
Embolism
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Vascular disorders
Flushing
|
7.0%
3/43 • Number of events 3
|
0.00%
0/84
|
0.00%
0/84
|
|
Vascular disorders
Hot flush
|
4.7%
2/43 • Number of events 2
|
0.00%
0/84
|
0.00%
0/84
|
|
Vascular disorders
Hypertension
|
7.0%
3/43 • Number of events 4
|
2.4%
2/84 • Number of events 2
|
11.9%
10/84 • Number of events 11
|
|
Vascular disorders
Hypotension
|
4.7%
2/43 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Vascular disorders
Phlebitis
|
4.7%
2/43 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
9.3%
4/43 • Number of events 4
|
23.8%
20/84 • Number of events 22
|
21.4%
18/84 • Number of events 21
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
3.6%
3/84 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.3%
1/43 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
0.00%
0/84
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.7%
2/43 • Number of events 3
|
2.4%
2/84 • Number of events 2
|
3.6%
3/84 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.3%
10/43 • Number of events 12
|
10.7%
9/84 • Number of events 26
|
20.2%
17/84 • Number of events 19
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
1/43 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
3.6%
3/84 • Number of events 4
|
|
Cardiac disorders
Atrial flutter
|
4.7%
2/43 • Number of events 2
|
0.00%
0/84
|
0.00%
0/84
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Cardiac disorders
Cardiac failure congestive
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Cardiac disorders
Sinus tachycardia
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/43
|
2.4%
2/84 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
2.3%
1/43 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Blepharitis
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Chorioretinal disorder
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Dry eye
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
|
Eye disorders
Eye discharge
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Eye disorder
|
0.00%
0/43
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Eye disorders
Eye irritation
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Eye oedema
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Eye pain
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Eye disorders
Eye swelling
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 5
|
|
Eye disorders
Eyelid pain
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Eye disorders
Lacrimation increased
|
4.7%
2/43 • Number of events 2
|
2.4%
2/84 • Number of events 2
|
8.3%
7/84 • Number of events 7
|
|
Eye disorders
Noninfective conjunctivitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
3.6%
3/84 • Number of events 4
|
|
Eye disorders
Vision blurred
|
0.00%
0/43
|
4.8%
4/84 • Number of events 4
|
3.6%
3/84 • Number of events 3
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Visual impairment
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/43
|
2.4%
2/84 • Number of events 2
|
0.00%
0/84
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/43
|
2.4%
2/84 • Number of events 3
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43 • Number of events 4
|
10.7%
9/84 • Number of events 12
|
7.1%
6/84 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.3%
4/43 • Number of events 5
|
3.6%
3/84 • Number of events 3
|
9.5%
8/84 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 2
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Buccal mucosal roughening
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
11.6%
5/43 • Number of events 5
|
19.0%
16/84 • Number of events 18
|
13.1%
11/84 • Number of events 13
|
|
Gastrointestinal disorders
Dental cyst
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
27.9%
12/43 • Number of events 21
|
48.8%
41/84 • Number of events 78
|
44.0%
37/84 • Number of events 65
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Gastrointestinal disorders
Dry mouth
|
2.3%
1/43 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
4.8%
4/84 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
9.3%
4/43 • Number of events 10
|
7.1%
6/84 • Number of events 6
|
4.8%
4/84 • Number of events 4
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
4.8%
4/84 • Number of events 4
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
7.1%
6/84 • Number of events 6
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Hiatus hernia
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 2
|
|
Gastrointestinal disorders
Lip erosion
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
4.8%
4/84 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
23.3%
10/43 • Number of events 22
|
29.8%
25/84 • Number of events 33
|
27.4%
23/84 • Number of events 36
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
11.6%
5/43 • Number of events 7
|
13.1%
11/84 • Number of events 11
|
27.4%
23/84 • Number of events 33
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
2.3%
1/43 • Number of events 2
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
18.6%
8/43 • Number of events 13
|
23.8%
20/84 • Number of events 28
|
26.2%
22/84 • Number of events 27
|
|
General disorders
Asthenia
|
4.7%
2/43 • Number of events 2
|
14.3%
12/84 • Number of events 12
|
15.5%
13/84 • Number of events 14
|
|
General disorders
Catheter site related reaction
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
General disorders
Chest discomfort
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
General disorders
Chest pain
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
General disorders
Chills
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
General disorders
Extravasation
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
General disorders
Face oedema
|
0.00%
0/43
|
4.8%
4/84 • Number of events 4
|
4.8%
4/84 • Number of events 4
|
|
General disorders
Fatigue
|
30.2%
13/43 • Number of events 17
|
20.2%
17/84 • Number of events 21
|
31.0%
26/84 • Number of events 32
|
|
General disorders
General physical health deterioration
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
|
General disorders
Generalised oedema
|
0.00%
0/43
|
0.00%
0/84
|
3.6%
3/84 • Number of events 3
|
|
General disorders
Hyperthermia
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
General disorders
Influenza like illness
|
2.3%
1/43 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
3.6%
3/84 • Number of events 3
|
|
General disorders
Malaise
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
8.3%
7/84 • Number of events 8
|
|
General disorders
Non-cardiac chest pain
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
General disorders
Oedema peripheral
|
18.6%
8/43 • Number of events 10
|
19.0%
16/84 • Number of events 22
|
33.3%
28/84 • Number of events 38
|
|
General disorders
Pain
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
General disorders
Performance status decreased
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
General disorders
Pyrexia
|
7.0%
3/43 • Number of events 5
|
13.1%
11/84 • Number of events 15
|
13.1%
11/84 • Number of events 20
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Immune system disorders
Drug hypersensitivity
|
4.7%
2/43 • Number of events 2
|
0.00%
0/84
|
0.00%
0/84
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
4.7%
2/43 • Number of events 2
|
2.4%
2/84 • Number of events 2
|
7.1%
6/84 • Number of events 6
|
|
Infections and infestations
Candida infection
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Conjunctivitis
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
6.0%
5/84 • Number of events 5
|
|
Infections and infestations
Diverticulitis
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Infections and infestations
Ear infection
|
0.00%
0/43
|
2.4%
2/84 • Number of events 2
|
0.00%
0/84
|
|
Infections and infestations
Erysipelas
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Folliculitis
|
4.7%
2/43 • Number of events 2
|
2.4%
2/84 • Number of events 2
|
2.4%
2/84 • Number of events 2
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 2
|
0.00%
0/84
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Gingivitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Laryngitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Lung infection
|
0.00%
0/43
|
4.8%
4/84 • Number of events 4
|
2.4%
2/84 • Number of events 2
|
|
Infections and infestations
Mastitis
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
3/43 • Number of events 3
|
4.8%
4/84 • Number of events 5
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Ophthalmic herpes zoster
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Infections and infestations
Oral candidiasis
|
7.0%
3/43 • Number of events 4
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/43
|
4.8%
4/84 • Number of events 5
|
1.2%
1/84 • Number of events 2
|
|
Infections and infestations
Oral infection
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Paronychia
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
8.3%
7/84 • Number of events 9
|
|
Infections and infestations
Peritonitis
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43 • Number of events 1
|
4.8%
4/84 • Number of events 4
|
3.6%
3/84 • Number of events 3
|
|
Infections and infestations
Rash pustular
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
6.0%
5/84 • Number of events 7
|
|
Infections and infestations
Respiratory tract infection
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Rhinitis
|
4.7%
2/43 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
|
Infections and infestations
Septic shock
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Skin infection
|
0.00%
0/43
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
4.7%
2/43 • Number of events 2
|
6.0%
5/84 • Number of events 7
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/43
|
0.00%
0/84
|
3.6%
3/84 • Number of events 4
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
1/43 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Sunburn
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/43
|
4.8%
4/84 • Number of events 4
|
0.00%
0/84
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/43
|
4.8%
4/84 • Number of events 4
|
2.4%
2/84 • Number of events 2
|
|
Investigations
Blood calcium decreased
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/43
|
3.6%
3/84 • Number of events 11
|
6.0%
5/84 • Number of events 11
|
|
Investigations
Blood creatinine increased
|
2.3%
1/43 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/43
|
2.4%
2/84 • Number of events 2
|
0.00%
0/84
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Investigations
Blood sodium decreased
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Investigations
Blood triglycerides increased
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
0.00%
0/84
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/43
|
0.00%
0/84
|
2.4%
2/84 • Number of events 2
|
|
Investigations
C-reactive protein increased
|
2.3%
1/43 • Number of events 1
|
0.00%
0/84
|
1.2%
1/84 • Number of events 2
|
|
Investigations
Ejection fraction decreased
|
4.7%
2/43 • Number of events 2
|
4.8%
4/84 • Number of events 4
|
2.4%
2/84 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Investigations
International normalised ratio increased
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
|
Investigations
Platelet count decreased
|
0.00%
0/43
|
0.00%
0/84
|
1.2%
1/84 • Number of events 1
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/43
|
1.2%
1/84 • Number of events 1
|
0.00%
0/84
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place