Trial Outcomes & Findings for Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia (NCT NCT01460160)
NCT ID: NCT01460160
Last Updated: 2021-12-08
Results Overview
3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following: * Lack of complete response in bone marrow * Relapse at any site * Development of second malignant neoplasm * Death from any cause
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
From first dose to 3 years following first dose
Results posted on
2021-12-08
Participant Flow
106 participants were treated with dasatinib.
Participant milestones
| Measure |
Dasatinib Cohort
Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
|
|---|---|
|
Treatment Phase
STARTED
|
106
|
|
Treatment Phase
COMPLETED
|
78
|
|
Treatment Phase
NOT COMPLETED
|
28
|
|
Follow-up Phase
STARTED
|
100
|
|
Follow-up Phase
COMPLETED
|
0
|
|
Follow-up Phase
NOT COMPLETED
|
100
|
Reasons for withdrawal
| Measure |
Dasatinib Cohort
Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
|
|---|---|
|
Treatment Phase
Lack of Efficacy
|
3
|
|
Treatment Phase
Study Drug Toxicity
|
2
|
|
Treatment Phase
Adverse Event
|
8
|
|
Treatment Phase
Withdrawal by Subject
|
4
|
|
Treatment Phase
Death
|
2
|
|
Treatment Phase
Other reasons
|
9
|
|
Follow-up Phase
Withdrawal by Subject
|
4
|
|
Follow-up Phase
Death
|
14
|
|
Follow-up Phase
Lost to Follow-up
|
7
|
|
Follow-up Phase
Follow-up no longer required per protocol
|
70
|
|
Follow-up Phase
Other and not reported reasons
|
5
|
Baseline Characteristics
All treated particpants
Baseline characteristics by cohort
| Measure |
Dasatinib Cohort
n=106 Participants
Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
|
|---|---|
|
Age, Continuous
|
9.29 Years
STANDARD_DEVIATION 4.467 • n=5 Participants • All treated particpants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants • All treated particpants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants • All treated particpants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants • All treated participants
|
PRIMARY outcome
Timeframe: From first dose to 3 years following first dosePopulation: All treated partcipants
3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following: * Lack of complete response in bone marrow * Relapse at any site * Development of second malignant neoplasm * Death from any cause
Outcome measures
| Measure |
Dasatinib Cohort
n=106 Participants
Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
|
|---|---|
|
3-year Event-free Survival (EFS) Rate
|
66.0 Percentage of Participants
Interval 57.7 to 73.7
|
SECONDARY outcome
Timeframe: From first dose to 100 days following last dose (up to approximately 23 months)Population: All treated participants
Number of participants experiencing different types of all causality all grade adverse events
Outcome measures
| Measure |
Dasatinib Cohort
n=106 Participants
Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
|
|---|---|
|
Number of Participants Experiencing Adverse Events
Adverse Events (AEs)
|
106 Participants
|
|
Number of Participants Experiencing Adverse Events
Drug-related AEs
|
88 Participants
|
|
Number of Participants Experiencing Adverse Events
AEs leading to discontinuation
|
7 Participants
|
|
Number of Participants Experiencing Adverse Events
Serious Adverse Events (SAEs)
|
101 Participants
|
|
Number of Participants Experiencing Adverse Events
Deaths
|
15 Participants
|
SECONDARY outcome
Timeframe: From first dose to 3 years or 5 years following first dosePopulation: All treated participants
Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.
Outcome measures
| Measure |
Dasatinib Cohort
n=106 Participants
Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
|
|---|---|
|
Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
3-year EFS Estimate
|
65.5 Percentage of Participants
Interval 55.5 to 73.7
|
|
Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
5-year EFS Estimate
|
53.1 Percentage of Participants
Interval 42.8 to 62.3
|
SECONDARY outcome
Timeframe: From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)Population: All treated participants
Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. \< 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.
Outcome measures
| Measure |
Dasatinib Cohort
n=106 Participants
Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
|
|---|---|
|
Complete Remission Rate
End of Induction period Ia
|
65.1 Percentage of Partcipants
|
|
Complete Remission Rate
End of Induction period Ib
|
88.7 Percentage of Partcipants
|
|
Complete Remission Rate
End of Consolidation period
|
93.4 Percentage of Partcipants
|
SECONDARY outcome
Timeframe: From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)Population: All treated participants
MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1%
Outcome measures
| Measure |
Dasatinib Cohort
n=106 Participants
Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
|
|---|---|
|
Percentage of Participants Negative for Minimal Residual Disease (MRD)
End of Induction period Ia
|
28.3 Percentage of Participants
Interval 19.98 to 37.88
|
|
Percentage of Participants Negative for Minimal Residual Disease (MRD)
End of Induction period Ib
|
52.8 Percentage of Participants
Interval 42.89 to 62.6
|
|
Percentage of Participants Negative for Minimal Residual Disease (MRD)
End of Consolidation period
|
71.7 Percentage of Participants
Interval 62.12 to 80.02
|
SECONDARY outcome
Timeframe: At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years)Population: All treated participants with available measurements
A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR.
Outcome measures
| Measure |
Dasatinib Cohort
n=106 Participants
Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
|
|---|---|
|
Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse
At Baseline
|
1.3 Percentage of participants
|
|
Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse
At Disease Progression or Relapse
|
6.5 Percentage of participants
|
Adverse Events
Dasatinib Cohort
Serious events: 101 serious events
Other events: 106 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Dasatinib Cohort
n=106 participants at risk
Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
12.3%
13/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
FEBRILE BONE MARROW APLASIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
76.4%
81/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
3.8%
4/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
LYMPHATIC DISORDER
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
23.6%
25/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Cardiac disorders
CARDIAC ARREST
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Cardiac disorders
TACHYCARDIA
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Eye disorders
PHOTOPHOBIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Eye disorders
VISION BLURRED
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.4%
11/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ASCITES
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
COLITIS
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
DIARRHOEA
|
19.8%
21/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
DIARRHOEA HAEMORRHAGIC
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ENTERITIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
GASTRIC PERFORATION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
GASTRITIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
GASTROINTESTINAL NECROSIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ILEUS
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
LARGE INTESTINAL ULCER
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
3.8%
4/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
NAUSEA
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
NEUTROPENIC COLITIS
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
PROCTITIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
STOMATITIS
|
14.2%
15/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
VOMITING
|
15.1%
16/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
CHILLS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
DEVICE RELATED THROMBOSIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
LOCALISED OEDEMA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
MUCOSAL INFLAMMATION
|
17.0%
18/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
OEDEMA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
OEDEMA PERIPHERAL
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
PAIN
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
PYREXIA
|
49.1%
52/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Hepatobiliary disorders
HEPATITIS TOXIC
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Hepatobiliary disorders
VENOOCCLUSIVE LIVER DISEASE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
ABDOMINAL INFECTION
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
BACTERAEMIA
|
13.2%
14/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
BACTERIAL SEPSIS
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
BRONCHITIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CANDIDA INFECTION
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CANDIDA PNEUMONIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CELLULITIS
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CLOSTRIDIAL INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
COCCIDIOIDOMYCOSIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CONJUNCTIVITIS
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
13.2%
14/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
EMPYEMA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
ENTEROCOLITIS BACTERIAL
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
FUNGAL SEPSIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
GASTROENTERITIS
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
HEPATIC INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
HERPES ZOSTER
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
INFECTION
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
INFLUENZA
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
KIDNEY INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
KLEBSIELLA BACTERAEMIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
LOCALISED INFECTION
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
LUNG INFECTION
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
MUCOSAL INFECTION
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
NAIL BED INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
NAIL INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
NEUTROPENIC INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
OSTEOMYELITIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
OTITIS MEDIA
|
4.7%
5/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PASTEURELLA INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PELVIC INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PERINEAL CELLULITIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PERIORBITAL CELLULITIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PERITONITIS
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PHARYNGITIS
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PNEUMONIA
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PSEUDOMONAL BACTERAEMIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
RASH PUSTULAR
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
SEPSIS
|
18.9%
20/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
SEPTIC EMBOLUS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
SEPTIC SHOCK
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
SINUSITIS
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
SKIN INFECTION
|
3.8%
4/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
SPLENIC INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
STREPTOCOCCAL SEPSIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
SYSTEMIC CANDIDA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
SYSTEMIC MYCOSIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
TOOTH ABSCESS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
TOOTH INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
URINARY TRACT INFECTION ENTEROCOCCAL
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
VIRAL DIARRHOEA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
ALLERGIC TRANSFUSION REACTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
ANAPHYLACTIC TRANSFUSION REACTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
TRAUMATIC FRACTURE
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS COMPLICATION
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
4.7%
5/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
BLOOD CREATININE INCREASED
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
BLOOD CULTURE POSITIVE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
DRUG CLEARANCE DECREASED
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
ENTEROVIRUS TEST POSITIVE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
8.5%
9/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
PLATELET COUNT DECREASED
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
TRANSAMINASES INCREASED
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
TROPONIN I INCREASED
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
URINE OUTPUT DECREASED
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
VIRAL TEST
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
WEIGHT DECREASED
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
10.4%
11/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
8.5%
9/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.7%
5/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE LYMPHOCYTIC LEUKAEMIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ASTROCYTOMA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKAEMIA RECURRENT
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
DYSARTHRIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
ENCEPHALOPATHY
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
FACIAL PARESIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
HEADACHE
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
HEMIPARESIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
LEUKOENCEPHALOPATHY
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
PARAESTHESIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME
|
3.8%
4/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
PRESYNCOPE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
SEIZURE
|
4.7%
5/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Psychiatric disorders
ANXIETY
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Psychiatric disorders
DELIRIUM
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Psychiatric disorders
PERSONALITY CHANGE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Renal and urinary disorders
HAEMATURIA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Reproductive system and breast disorders
OEDEMA GENITAL
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
CHYLOTHORAX
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.8%
4/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
1.9%
2/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
8.5%
9/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
STRIDOR
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
RASH
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.94%
1/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Vascular disorders
EMBOLISM
|
2.8%
3/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Vascular disorders
HYPERTENSION
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Vascular disorders
HYPOTENSION
|
20.8%
22/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
Other adverse events
| Measure |
Dasatinib Cohort
n=106 participants at risk
Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
|
|---|---|
|
General disorders
OEDEMA
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
OEDEMA PERIPHERAL
|
16.0%
17/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
PAIN
|
26.4%
28/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
ANAEMIA
|
78.3%
83/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
34.9%
37/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
11.3%
12/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
40.6%
43/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
47.2%
50/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
17.9%
19/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Cardiac disorders
TACHYCARDIA
|
33.0%
35/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Ear and labyrinth disorders
EAR PAIN
|
23.6%
25/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Eye disorders
EYE PAIN
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Eye disorders
OCULAR HYPERAEMIA
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Eye disorders
PERIORBITAL OEDEMA
|
8.5%
9/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Eye disorders
VISION BLURRED
|
14.2%
15/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
10.4%
11/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
68.9%
73/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
17.9%
19/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ANAL INFLAMMATION
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
COLITIS
|
12.3%
13/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
CONSTIPATION
|
54.7%
58/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
DIARRHOEA
|
70.8%
75/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
13.2%
14/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
NAUSEA
|
76.4%
81/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
ORAL PAIN
|
25.5%
27/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
PROCTALGIA
|
14.2%
15/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
STOMATITIS
|
46.2%
49/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
TOOTHACHE
|
8.5%
9/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Gastrointestinal disorders
VOMITING
|
78.3%
83/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
ASTHENIA
|
10.4%
11/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
CATHETER SITE ERYTHEMA
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
CATHETER SITE PAIN
|
13.2%
14/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
CHILLS
|
18.9%
20/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
FACE OEDEMA
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
FATIGUE
|
54.7%
58/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
GAIT DISTURBANCE
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
MALAISE
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
MUCOSAL INFLAMMATION
|
48.1%
51/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
17.0%
18/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
General disorders
PYREXIA
|
74.5%
79/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
16.0%
17/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CANDIDA INFECTION
|
10.4%
11/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CELLULITIS
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
10.4%
11/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
CONJUNCTIVITIS
|
11.3%
12/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
EAR INFECTION
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
INFLUENZA
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
LUNG INFECTION
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
ORAL CANDIDIASIS
|
13.2%
14/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
OTITIS MEDIA
|
10.4%
11/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PHARYNGITIS
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
PNEUMONIA
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
RHINITIS
|
10.4%
11/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
RHINOVIRUS INFECTION
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
SEPSIS
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
SINUSITIS
|
17.0%
18/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
SKIN INFECTION
|
11.3%
12/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
36.8%
39/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
13.2%
14/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
8.5%
9/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
ALLERGIC TRANSFUSION REACTION
|
12.3%
13/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
CONTUSION
|
30.2%
32/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
SUNBURN
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
39.6%
42/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
33.0%
35/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
11.3%
12/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
BLOOD CREATININE INCREASED
|
8.5%
9/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
CARDIAC MURMUR
|
11.3%
12/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
38.7%
41/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
PLATELET COUNT DECREASED
|
36.8%
39/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
WEIGHT DECREASED
|
24.5%
26/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
WEIGHT INCREASED
|
10.4%
11/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
19.8%
21/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
37.7%
40/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
13.2%
14/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
21.7%
23/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
32.1%
34/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
28.3%
30/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
47.2%
50/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
17.9%
19/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
21.7%
23/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
21.7%
23/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
35.8%
38/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
45.3%
48/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
20.8%
22/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
19.8%
21/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
14.2%
15/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
14.2%
15/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
8.5%
9/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
59.4%
63/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
17.0%
18/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
DIZZINESS
|
13.2%
14/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
HEADACHE
|
66.0%
70/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
LETHARGY
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
11.3%
12/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
12.3%
13/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Nervous system disorders
TREMOR
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Psychiatric disorders
AGITATION
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Psychiatric disorders
ANXIETY
|
14.2%
15/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Psychiatric disorders
DEPRESSION
|
15.1%
16/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Psychiatric disorders
INSOMNIA
|
15.1%
16/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Psychiatric disorders
IRRITABILITY
|
11.3%
12/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Renal and urinary disorders
DYSURIA
|
11.3%
12/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Renal and urinary disorders
HAEMATURIA
|
12.3%
13/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Renal and urinary disorders
URINARY RETENTION
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
73.6%
78/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
17.0%
18/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
25.5%
27/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
14.2%
15/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
26.4%
28/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
33.0%
35/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
15.1%
16/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
34.9%
37/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNOEA
|
10.4%
11/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
12.3%
13/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
19.8%
21/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
8.5%
9/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
17.9%
19/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
6.6%
7/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
20.8%
22/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
16.0%
17/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
25.5%
27/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
RASH
|
45.3%
48/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
19.8%
21/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
7.5%
8/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
SWELLING FACE
|
8.5%
9/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
8.5%
9/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Vascular disorders
FLUSHING
|
9.4%
10/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Vascular disorders
HAEMATOMA
|
5.7%
6/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Vascular disorders
HYPERTENSION
|
38.7%
41/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Vascular disorders
HYPOTENSION
|
26.4%
28/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
|
Vascular disorders
PALLOR
|
10.4%
11/106 • All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER