Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01460160
Recruitment Status : Active, not recruiting
First Posted : October 26, 2011
Results First Posted : August 21, 2018
Last Update Posted : July 8, 2020
Sponsor:
Collaborators:
Children's Oncology Group
EsPhALL
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia, Pediatric
Intervention Drug: Dasatinib
Enrollment 109
Recruitment Details  
Pre-assignment Details A total of 109 participants were enrolled and 106 participants were treated with dasatinib (82 participants received dasatinib in the tablet form exclusively and 24 participants received either tablet and/or PFOS).
Arm/Group Title Tablet Only PFOS Used
Hide Arm/Group Description For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range. If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
Period Title: Treatment
Started 82 24
Completed 59 19
Not Completed 23 5
Reason Not Completed
Lack of Efficacy             3             0
Study Drug Toxicity             2             0
Adverse Event             8             0
Withdrawal by Subject             4             0
Death             0             2
PI decision to not re-initiate after SCT             2             2
PI not to follow protocol therapy             1             0
PI decision to pursue other options             1             1
Family did not wish to restart after SCT             1             0
Subject refused to continue Chemo             1             0
Period Title: Follow-up
Started 78 22
Completed [1] 67 20
Not Completed 11 2
Reason Not Completed
Withdrawal by Subject             3             0
Death             7             2
Lost to Follow-up             1             0
[1]
Completed = Continuing in follow-up (ongoing)
Arm/Group Title Tablet Only PFOS Used Total
Hide Arm/Group Description For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range. If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice. Total of all reporting groups
Overall Number of Baseline Participants 82 24 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 24 participants 106 participants
10.33  (4.160) 5.73  (3.612) 9.29  (4.467)
[1]
Measure Analysis Population Description: All treated particpants
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 24 participants 106 participants
Female
37
  45.1%
12
  50.0%
49
  46.2%
Male
45
  54.9%
12
  50.0%
57
  53.8%
[1]
Measure Analysis Population Description: All treated particpants
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 24 participants 106 participants
American Indian or Alaska Native
0
   0.0%
1
   4.2%
1
   0.9%
Asian
5
   6.1%
0
   0.0%
5
   4.7%
Native Hawaiian or Other Pacific Islander
1
   1.2%
0
   0.0%
1
   0.9%
Black or African American
9
  11.0%
4
  16.7%
13
  12.3%
White
66
  80.5%
19
  79.2%
85
  80.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.2%
0
   0.0%
1
   0.9%
[1]
Measure Analysis Population Description: All treated participants
BCR-ABL Mutation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 24 participants 106 participants
P190
60
  73.2%
15
  62.5%
75
  70.8%
P210
11
  13.4%
5
  20.8%
16
  15.1%
1.Primary Outcome
Title Percentage of Participants With 3-year Event-free Survival (EFS)
Hide Description

EFS is defined as the time from the starting date of dasatinib until an event. In the primary analysis, the 3-year EFS response rate is defined as the number of participants without event after 3 years since the start of dasatinib divided by the number of treated participants and expressed as a percentage. 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
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Tablet Only PFOS Used All Treated Participants
Hide Arm/Group Description:
For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range.
If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
All participants receiving at least one dose of study treatment (tablet or PFOS)
Overall Number of Participants Analyzed 82 24 106
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of Participants
65.9
(56.3 to 74.5)
66.7
(47.9 to 82.2)
66.0
(57.7 to 73.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tablet Only, PFOS Used
Comments Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in AIEOP-BFM 2000 historical control
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments Superiority test versus AIEOP-BFM 2000
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of Difference
Estimated Value 16.86
Confidence Interval (2-Sided) 90%
3.9 to 29.8
Estimation Comments Treatment difference (CA180372 - AIEOP-BFM 2000)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tablet Only, PFOS Used
Comments Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control
Type of Statistical Test Non-Inferiority
Comments non-inferiority margin = 5%. One-sided type I error rate of 0.05
Statistical Test of Hypothesis P-Value 0.271
Comments Superiority test versus EsPhALL
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 6.91
Confidence Interval (2-Sided) 90%
-3.3 to 17.2
Estimation Comments Treatment difference (CA180372 - EsPhALL) Test if lower confidence limit is above -5%
2.Secondary Outcome
Title Percentage of Participants With 3-year EFS Rate (K-M Estimate)
Hide Description Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-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.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Tablet Only PFOS Used All Treated Participants
Hide Arm/Group Description:
For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range.
If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
All participants receiving at least one dose of study treatment (tablet or PFOS)
Overall Number of Participants Analyzed 82 24 106
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
65.1
(53.6 to 74.4)
66.7
(44.3 to 81.7)
65.5
(55.5 to 73.7)
3.Secondary Outcome
Title Overall Survival (K-M Estimate) Rate at 3 Years
Hide Description Overall survival is defined as time from the first day of dasatinib treatment until the time of death. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The rate of OS at 3 years was expressed as a percentage of all treated participants.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Tablet Only PFOS Used All Treated Participants
Hide Arm/Group Description:
For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range.
If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
All participants receiving at least one dose of study treatment (tablet or PFOS)
Overall Number of Participants Analyzed 82 24 106
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
92.6
(84.3 to 96.6)
87.5
(66.1 to 95.8)
91.5
(84.2 to 95.5)
4.Secondary Outcome
Title Complete Remission Rate
Hide Description CR rate is defined as the proportion of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease, and expressed as a percentage. 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.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Tablet Only PFOS Used All Treated Participants
Hide Arm/Group Description:
For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range.
If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
All participants receiving at least one dose of study treatment (tablet or PFOS)
Overall Number of Participants Analyzed 82 24 106
Measure Type: Number
Unit of Measure: Percentage of Partcipants
End of Induction period (period IA) 64.6 66.7 65.1
End of Induction period (period IB) 87.8 91.7 88.7
End of Consolidation period 93.9 91.7 93.4
5.Secondary Outcome
Title Percentage of Participants With Minimal Residual Disease Based on Ig/TCR Method
Hide Description The number of participants with MRD at the end of the Induction 1B and Consolidation periods was divided by the number of treated participants and expressed as a percentage.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Tablet Only PFOS Used All Treated Participants
Hide Arm/Group Description:
For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range.
If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
All participants receiving at least one dose of study treatment (tablet or PFOS)
Overall Number of Participants Analyzed 82 24 106
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
MRD-negative, end of Induction IB period
53.7
(42.30 to 64.75)
50.0
(29.12 to 70.88)
52.8
(42.89 to 62.60)
MRD-negative, end of Consolidation
74.4
(63.56 to 83.40)
62.5
(40.59 to 81.20)
71.7
(62.12 to 80.02)
6.Secondary Outcome
Title Number of Participants With AEs or Drug Related Death
Hide Description The number of participants with any AE or with study drug-related death was reported for each arm.
Time Frame Approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Tablet Only PFOS Used All Treated Participants
Hide Arm/Group Description:
For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range.
If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
All participants receiving at least one dose of study treatment (tablet or PFOS)
Overall Number of Participants Analyzed 82 24 106
Measure Type: Number
Unit of Measure: Participants
AEs 82 24 106
Drug Related Death 0 0 0
7.Secondary Outcome
Title Number of Participants With BCR-ABL Mutations at Time of Disease Progression
Hide Description The number of Ph+ ALL participants with BCR-ABL Mutations at Disease Progression or Relapse was reported for each arm.
Time Frame Approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Ph+ ALL participants with mutation data at both baseline and disease progression
Arm/Group Title Tablet Only PFOS Used All Treated Participants
Hide Arm/Group Description:
For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range.
If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
All participants receiving at least one dose of study treatment (tablet or PFOS)
Overall Number of Participants Analyzed 25 6 106
Measure Type: Number
Unit of Measure: participants
Number of participants with mutations 2 0 2
Number of participants with no mutations 17 3 20
Not Reported 6 3 9
8.Secondary Outcome
Title Number of Participants With Grade 3-4 Hematology Laboratory Abnormalities.
Hide Description The number of participants experiencing Grade 3 or 4 hematology laboratory abnormalities was reported by arm.
Time Frame Approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Tablet Only PFOS Used All Treated Participants
Hide Arm/Group Description:
For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range.
If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
All participants receiving at least one dose of study treatment (tablet or PFOS)
Overall Number of Participants Analyzed 82 24 106
Measure Type: Number
Unit of Measure: participants
Leukocytes 77 23 100
Absolute Neutrophil Count 79 24 103
Platelet Count 72 21 93
Hemoglobin 67 21 88
9.Secondary Outcome
Title Number of Participants With Grade 3-4 Liver Function Laboratory Abnormalities.
Hide Description The number of participants experiencing Grade 3 or 4 liver function laboratory abnormalities was reported by arm.
Time Frame Approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Tablet Only PFOS Used All Treated Participants
Hide Arm/Group Description:
For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range.
If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
All participants receiving at least one dose of study treatment (tablet or PFOS)
Overall Number of Participants Analyzed 82 24 106
Measure Type: Number
Unit of Measure: participants
ALT 38 15 53
AST 21 7 28
Total bilirubin 9 0 9
10.Secondary Outcome
Title Number of Participants With Grade 3-4 Kidney Function Abnormalities
Hide Description The number of participants experiencing Grade 3 or 4 kidney function laboratory abnormalities was reported by arm.
Time Frame Approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Tablet Only PFOS Used All Treated Participants
Hide Arm/Group Description:
For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range.
If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
All participants receiving at least one dose of study treatment (tablet or PFOS)
Overall Number of Participants Analyzed 82 24 106
Measure Type: Number
Unit of Measure: participants
BUN/Urea >ULN 33 7 40
Serum Creatinine 2 0 2
11.Secondary Outcome
Title Number of Participants With Grade 3-4 Serum Chemistry Abnormalities
Hide Description The number of participants with grade 3-4 serum chemistry laboratory abnormalities was presented for each arm.
Time Frame Approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Tablet Only PFOS Used All Treated Participants
Hide Arm/Group Description:
For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range.
If necessary for administration in young children not able to swallow tablets, dasatinib was dispersed as Powder For Oral Suspension (PFOS) at a dose of 60 mg/m2 daily in 100% preservative-free juice.
All participants receiving at least one dose of study treatment (tablet or PFOS)
Overall Number of Participants Analyzed 82 24 106
Measure Type: Number
Unit of Measure: participants
HC03<LLN (All Grade) 27 11 38
HC03>ULN (All Grade) 24 1 25
LDH>ULN (All Grade) 63 18 81
Sodium 15 3 18
Potassium 33 10 43
Chloride (low) < LLN 20 2 22
Chloride(high) > ULN 29 11 40
Magnesium (low) 1 0 1
Phosphorus 9 4 13
Calcium (low) 15 3 18
Uric Acid 0 1 1
Time Frame From first dose to date of last dose plus 30 days (Assessed approximately 3 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tablet Only TABLET ONLY
Hide Arm/Group Description For children and adolescents capable of swallowing tablets, dasatinib tablets in strengths of 5 mg, 20 mg, and 50 mg, were given to cover the anticipated dose range. The PFOS bottle was constituted with 77 mL Purified water or Sterile Water for Injection to give a total volume of 99 mL with a 10 mg/mL suspension
All-Cause Mortality
Tablet Only TABLET ONLY
Affected / at Risk (%) Affected / at Risk (%)
Total   2/24 (8.33%)   3/82 (3.66%) 
Hide Serious Adverse Events
Tablet Only TABLET ONLY
Affected / at Risk (%) Affected / at Risk (%)
Total   22/24 (91.67%)   79/82 (96.34%) 
Blood and lymphatic system disorders     
Anaemia  1  1/24 (4.17%)  12/82 (14.63%) 
Disseminated intravascular coagulation  1  0/24 (0.00%)  1/82 (1.22%) 
Febrile bone marrow aplasia  1  0/24 (0.00%)  1/82 (1.22%) 
Febrile neutropenia  1  20/24 (83.33%)  61/82 (74.39%) 
Haemorrhagic anaemia  1  0/24 (0.00%)  1/82 (1.22%) 
Leukopenia  1  1/24 (4.17%)  3/82 (3.66%) 
Lymphatic disorder  1  0/24 (0.00%)  1/82 (1.22%) 
Neutropenia  1  5/24 (20.83%)  20/82 (24.39%) 
Pancytopenia  1  0/24 (0.00%)  3/82 (3.66%) 
Thrombocytopenia  1  1/24 (4.17%)  9/82 (10.98%) 
Cardiac disorders     
Cardiac arrest  1  0/24 (0.00%)  1/82 (1.22%) 
Cardiac failure  1  0/24 (0.00%)  1/82 (1.22%) 
Left ventricular dysfunction  1  0/24 (0.00%)  1/82 (1.22%) 
Pericardial effusion  1  1/24 (4.17%)  0/82 (0.00%) 
Sinus tachycardia  1  0/24 (0.00%)  3/82 (3.66%) 
Tachycardia  1  1/24 (4.17%)  1/82 (1.22%) 
Ear and labyrinth disorders     
Hypoacusis  1  1/24 (4.17%)  0/82 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  0/24 (0.00%)  1/82 (1.22%) 
Eye disorders     
Photophobia  1  0/24 (0.00%)  1/82 (1.22%) 
Vision blurred  1  0/24 (0.00%)  1/82 (1.22%) 
Gastrointestinal disorders     
Abdominal pain  1  1/24 (4.17%)  10/82 (12.20%) 
Abdominal pain lower  1  0/24 (0.00%)  1/82 (1.22%) 
Anal haemorrhage  1  0/24 (0.00%)  1/82 (1.22%) 
Ascites  1  0/24 (0.00%)  2/82 (2.44%) 
Colitis  1  2/24 (8.33%)  8/82 (9.76%) 
Constipation  1  1/24 (4.17%)  2/82 (2.44%) 
Diarrhoea  1  6/24 (25.00%)  15/82 (18.29%) 
Diarrhoea haemorrhagic  1  0/24 (0.00%)  1/82 (1.22%) 
Enteritis  1  0/24 (0.00%)  1/82 (1.22%) 
Enterocolitis  1  0/24 (0.00%)  2/82 (2.44%) 
Gastric haemorrhage  1  0/24 (0.00%)  1/82 (1.22%) 
Gastric perforation  1  0/24 (0.00%)  1/82 (1.22%) 
Gastritis  1  0/24 (0.00%)  1/82 (1.22%) 
Gastrointestinal haemorrhage  1  1/24 (4.17%)  0/82 (0.00%) 
Gastrointestinal necrosis  1  0/24 (0.00%)  1/82 (1.22%) 
Haematochezia  1  0/24 (0.00%)  1/82 (1.22%) 
Ileus  1  1/24 (4.17%)  1/82 (1.22%) 
Intestinal perforation  1  0/24 (0.00%)  1/82 (1.22%) 
Large intestinal ulcer  1  0/24 (0.00%)  1/82 (1.22%) 
Lower gastrointestinal haemorrhage  1  1/24 (4.17%)  3/82 (3.66%) 
Nausea  1  2/24 (8.33%)  4/82 (4.88%) 
Neutropenic colitis  1  1/24 (4.17%)  6/82 (7.32%) 
Oesophagitis  1  0/24 (0.00%)  1/82 (1.22%) 
Pancreatitis  1  0/24 (0.00%)  1/82 (1.22%) 
Pancreatitis acute  1  1/24 (4.17%)  0/82 (0.00%) 
Proctalgia  1  0/24 (0.00%)  1/82 (1.22%) 
Proctitis  1  0/24 (0.00%)  1/82 (1.22%) 
Rectal haemorrhage  1  0/24 (0.00%)  1/82 (1.22%) 
Stomatitis  1  1/24 (4.17%)  14/82 (17.07%) 
Upper gastrointestinal haemorrhage  1  0/24 (0.00%)  1/82 (1.22%) 
Vomiting  1  3/24 (12.50%)  13/82 (15.85%) 
General disorders     
Chills  1  0/24 (0.00%)  1/82 (1.22%) 
Device related thrombosis  1  0/24 (0.00%)  1/82 (1.22%) 
Influenza like illness  1  0/24 (0.00%)  1/82 (1.22%) 
Localised oedema  1  0/24 (0.00%)  1/82 (1.22%) 
Mucosal inflammation  1  7/24 (29.17%)  11/82 (13.41%) 
Non-cardiac chest pain  1  0/24 (0.00%)  2/82 (2.44%) 
Oedema  1  0/24 (0.00%)  1/82 (1.22%) 
Oedema peripheral  1  0/24 (0.00%)  1/82 (1.22%) 
Pain  1  2/24 (8.33%)  1/82 (1.22%) 
Pyrexia  1  13/24 (54.17%)  39/82 (47.56%) 
Hepatobiliary disorders     
Cholecystitis  1  0/24 (0.00%)  1/82 (1.22%) 
Hepatitis toxic  1  0/24 (0.00%)  1/82 (1.22%) 
Venoocclusive liver disease  1  0/24 (0.00%)  1/82 (1.22%) 
Immune system disorders     
Anaphylactic reaction  1  0/24 (0.00%)  7/82 (8.54%) 
Drug hypersensitivity  1  1/24 (4.17%)  6/82 (7.32%) 
Infections and infestations     
Abdominal infection  1  0/24 (0.00%)  2/82 (2.44%) 
Bacteraemia  1  3/24 (12.50%)  11/82 (13.41%) 
Bacterial sepsis  1  2/24 (8.33%)  1/82 (1.22%) 
Bronchitis  1  0/24 (0.00%)  1/82 (1.22%) 
Candida infection  1  0/24 (0.00%)  3/82 (3.66%) 
Candida pneumonia  1  0/24 (0.00%)  1/82 (1.22%) 
Catheter site infection  1  0/24 (0.00%)  1/82 (1.22%) 
Cellulitis  1  0/24 (0.00%)  3/82 (3.66%) 
Cellulitis of male external genital organ  1  0/24 (0.00%)  1/82 (1.22%) 
Clostridial infection  1  0/24 (0.00%)  1/82 (1.22%) 
Clostridium difficile colitis  1  0/24 (0.00%)  6/82 (7.32%) 
Clostridium difficile infection  1  1/24 (4.17%)  6/82 (7.32%) 
Coccidioidomycosis  1  0/24 (0.00%)  1/82 (1.22%) 
Conjunctivitis  1  0/24 (0.00%)  3/82 (3.66%) 
Cytomegalovirus infection  1  0/24 (0.00%)  1/82 (1.22%) 
Device related infection  1  1/24 (4.17%)  13/82 (15.85%) 
Empyema  1  0/24 (0.00%)  1/82 (1.22%) 
Enterocolitis bacterial  1  1/24 (4.17%)  1/82 (1.22%) 
Enterocolitis infectious  1  0/24 (0.00%)  1/82 (1.22%) 
Escherichia bacteraemia  1  0/24 (0.00%)  2/82 (2.44%) 
Escherichia sepsis  1  1/24 (4.17%)  1/82 (1.22%) 
Escherichia urinary tract infection  1  0/24 (0.00%)  1/82 (1.22%) 
Fungal sepsis  1  0/24 (0.00%)  1/82 (1.22%) 
Gastroenteritis  1  0/24 (0.00%)  2/82 (2.44%) 
Hepatic infection  1  0/24 (0.00%)  1/82 (1.22%) 
Herpes zoster  1  1/24 (4.17%)  2/82 (2.44%) 
Infection  1  1/24 (4.17%)  1/82 (1.22%) 
Influenza  1  0/24 (0.00%)  3/82 (3.66%) 
Kidney infection  1  0/24 (0.00%)  1/82 (1.22%) 
Klebsiella bacteraemia  1  1/24 (4.17%)  0/82 (0.00%) 
Localised infection  1  0/24 (0.00%)  2/82 (2.44%) 
Lower respiratory tract infection  1  0/24 (0.00%)  2/82 (2.44%) 
Lung infection  1  4/24 (16.67%)  6/82 (7.32%) 
Mucosal infection  1  0/24 (0.00%)  2/82 (2.44%) 
Nail bed infection  1  0/24 (0.00%)  1/82 (1.22%) 
Nail infection  1  0/24 (0.00%)  1/82 (1.22%) 
Neutropenic infection  1  1/24 (4.17%)  0/82 (0.00%) 
Osteomyelitis  1  0/24 (0.00%)  1/82 (1.22%) 
Otitis media  1  2/24 (8.33%)  3/82 (3.66%) 
Pasteurella infection  1  0/24 (0.00%)  1/82 (1.22%) 
Pelvic infection  1  0/24 (0.00%)  1/82 (1.22%) 
Perineal cellulitis  1  0/24 (0.00%)  1/82 (1.22%) 
Periorbital cellulitis  1  1/24 (4.17%)  0/82 (0.00%) 
Peritonitis  1  0/24 (0.00%)  2/82 (2.44%) 
Pharyngitis  1  0/24 (0.00%)  2/82 (2.44%) 
Pneumonia  1  3/24 (12.50%)  7/82 (8.54%) 
Pneumonia bacterial  1  0/24 (0.00%)  1/82 (1.22%) 
Pneumonia viral  1  0/24 (0.00%)  1/82 (1.22%) 
Postoperative wound infection  1  1/24 (4.17%)  0/82 (0.00%) 
Pseudomonal bacteraemia  1  0/24 (0.00%)  1/82 (1.22%) 
Rash pustular  1  1/24 (4.17%)  1/82 (1.22%) 
Respiratory syncytial virus infection  1  0/24 (0.00%)  1/82 (1.22%) 
Sepsis  1  3/24 (12.50%)  17/82 (20.73%) 
Septic embolus  1  0/24 (0.00%)  1/82 (1.22%) 
Septic shock  1  1/24 (4.17%)  5/82 (6.10%) 
Sinusitis  1  1/24 (4.17%)  2/82 (2.44%) 
Skin infection  1  0/24 (0.00%)  4/82 (4.88%) 
Splenic infection  1  0/24 (0.00%)  1/82 (1.22%) 
Streptococcal sepsis  1  0/24 (0.00%)  1/82 (1.22%) 
Systemic candida  1  0/24 (0.00%)  1/82 (1.22%) 
Systemic mycosis  1  1/24 (4.17%)  0/82 (0.00%) 
Tooth abscess  1  0/24 (0.00%)  1/82 (1.22%) 
Tooth infection  1  0/24 (0.00%)  1/82 (1.22%) 
Upper respiratory tract infection  1  0/24 (0.00%)  1/82 (1.22%) 
Urinary tract infection  1  0/24 (0.00%)  3/82 (3.66%) 
Urinary tract infection enterococcal  1  0/24 (0.00%)  1/82 (1.22%) 
Viral diarrhoea  1  1/24 (4.17%)  0/82 (0.00%) 
Viral upper respiratory tract infection  1  0/24 (0.00%)  1/82 (1.22%) 
Injury, poisoning and procedural complications     
Allergic transfusion reaction  1  0/24 (0.00%)  1/82 (1.22%) 
Anaphylactic transfusion reaction  1  0/24 (0.00%)  1/82 (1.22%) 
Infusion related reaction  1  0/24 (0.00%)  2/82 (2.44%) 
Overdose  1  1/24 (4.17%)  0/82 (0.00%) 
Toxicity to various agents  1  0/24 (0.00%)  1/82 (1.22%) 
Transfusion reaction  1  0/24 (0.00%)  1/82 (1.22%) 
Traumatic fracture  1  1/24 (4.17%)  1/82 (1.22%) 
Vascular access complication  1  1/24 (4.17%)  1/82 (1.22%) 
Investigations     
Alanine aminotransferase increased  1  3/24 (12.50%)  2/82 (2.44%) 
Aspartate aminotransferase increased  1  1/24 (4.17%)  2/82 (2.44%) 
Blood bilirubin increased  1  0/24 (0.00%)  2/82 (2.44%) 
Blood creatinine increased  1  0/24 (0.00%)  7/82 (8.54%) 
Blood culture positive  1  0/24 (0.00%)  1/82 (1.22%) 
Drug clearance decreased  1  1/24 (4.17%)  1/82 (1.22%) 
Enterovirus test positive  1  1/24 (4.17%)  0/82 (0.00%) 
Neutrophil count decreased  1  1/24 (4.17%)  8/82 (9.76%) 
Platelet count decreased  1  0/24 (0.00%)  7/82 (8.54%) 
Transaminases increased  1  0/24 (0.00%)  1/82 (1.22%) 
Troponin i increased  1  0/24 (0.00%)  1/82 (1.22%) 
Urine output decreased  1  0/24 (0.00%)  1/82 (1.22%) 
Viral test  1  1/24 (4.17%)  1/82 (1.22%) 
Weight decreased  1  0/24 (0.00%)  3/82 (3.66%) 
White blood cell count decreased  1  1/24 (4.17%)  5/82 (6.10%) 
White blood cell count increased  1  0/24 (0.00%)  1/82 (1.22%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/24 (0.00%)  3/82 (3.66%) 
Dehydration  1  3/24 (12.50%)  8/82 (9.76%) 
Hyperglycaemia  1  0/24 (0.00%)  2/82 (2.44%) 
Hyperkalaemia  1  0/24 (0.00%)  2/82 (2.44%) 
Hypernatraemia  1  0/24 (0.00%)  1/82 (1.22%) 
Hypertriglyceridaemia  1  0/24 (0.00%)  1/82 (1.22%) 
Hypoalbuminaemia  1  0/24 (0.00%)  3/82 (3.66%) 
Hypokalaemia  1  2/24 (8.33%)  7/82 (8.54%) 
Hyponatraemia  1  1/24 (4.17%)  7/82 (8.54%) 
Hypophosphataemia  1  0/24 (0.00%)  2/82 (2.44%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/24 (0.00%)  2/82 (2.44%) 
Bone pain  1  0/24 (0.00%)  2/82 (2.44%) 
Muscular weakness  1  1/24 (4.17%)  2/82 (2.44%) 
Musculoskeletal chest pain  1  0/24 (0.00%)  2/82 (2.44%) 
Musculoskeletal pain  1  0/24 (0.00%)  1/82 (1.22%) 
Myalgia  1  0/24 (0.00%)  1/82 (1.22%) 
Osteonecrosis  1  0/24 (0.00%)  1/82 (1.22%) 
Pain in extremity  1  1/24 (4.17%)  4/82 (4.88%) 
Pain in jaw  1  0/24 (0.00%)  1/82 (1.22%) 
Rhabdomyolysis  1  1/24 (4.17%)  0/82 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute lymphocytic leukaemia  1  1/24 (4.17%)  0/82 (0.00%) 
Astrocytoma  1  0/24 (0.00%)  1/82 (1.22%) 
Leukaemia recurrent  1  1/24 (4.17%)  0/82 (0.00%) 
Nervous system disorders     
Cerebral ischaemia  1  0/24 (0.00%)  1/82 (1.22%) 
Cerebrovascular accident  1  0/24 (0.00%)  1/82 (1.22%) 
Depressed level of consciousness  1  0/24 (0.00%)  1/82 (1.22%) 
Dysarthria  1  0/24 (0.00%)  1/82 (1.22%) 
Encephalopathy  1  0/24 (0.00%)  2/82 (2.44%) 
Facial paresis  1  0/24 (0.00%)  1/82 (1.22%) 
Haemorrhage intracranial  1  0/24 (0.00%)  1/82 (1.22%) 
Headache  1  2/24 (8.33%)  6/82 (7.32%) 
Hemiparesis  1  0/24 (0.00%)  1/82 (1.22%) 
Leukoencephalopathy  1  0/24 (0.00%)  2/82 (2.44%) 
Paraesthesia  1  1/24 (4.17%)  0/82 (0.00%) 
Peripheral motor neuropathy  1  0/24 (0.00%)  2/82 (2.44%) 
Peripheral sensory neuropathy  1  0/24 (0.00%)  1/82 (1.22%) 
Posterior reversible encephalopathy syndrome  1  1/24 (4.17%)  3/82 (3.66%) 
Presyncope  1  0/24 (0.00%)  1/82 (1.22%) 
Seizure  1  1/24 (4.17%)  4/82 (4.88%) 
Psychiatric disorders     
Anxiety  1  0/24 (0.00%)  1/82 (1.22%) 
Delirium  1  1/24 (4.17%)  1/82 (1.22%) 
Personality change  1  0/24 (0.00%)  1/82 (1.22%) 
Renal and urinary disorders     
Acute kidney injury  1  1/24 (4.17%)  9/82 (10.98%) 
Bladder spasm  1  0/24 (0.00%)  1/82 (1.22%) 
Cystitis noninfective  1  0/24 (0.00%)  1/82 (1.22%) 
Haematuria  1  0/24 (0.00%)  1/82 (1.22%) 
Nephrolithiasis  1  0/24 (0.00%)  1/82 (1.22%) 
Urinary retention  1  0/24 (0.00%)  1/82 (1.22%) 
Urinary tract obstruction  1  0/24 (0.00%)  1/82 (1.22%) 
Reproductive system and breast disorders     
Oedema genital  1  0/24 (0.00%)  1/82 (1.22%) 
Respiratory, thoracic and mediastinal disorders     
Chylothorax  1  0/24 (0.00%)  1/82 (1.22%) 
Cough  1  2/24 (8.33%)  6/82 (7.32%) 
Dyspnoea  1  0/24 (0.00%)  4/82 (4.88%) 
Epistaxis  1  0/24 (0.00%)  2/82 (2.44%) 
Haemothorax  1  0/24 (0.00%)  1/82 (1.22%) 
Hypoxia  1  2/24 (8.33%)  5/82 (6.10%) 
Pleural effusion  1  1/24 (4.17%)  8/82 (9.76%) 
Pleuritic pain  1  0/24 (0.00%)  1/82 (1.22%) 
Pneumonitis  1  0/24 (0.00%)  3/82 (3.66%) 
Pulmonary oedema  1  0/24 (0.00%)  1/82 (1.22%) 
Respiratory distress  1  0/24 (0.00%)  1/82 (1.22%) 
Stridor  1  1/24 (4.17%)  0/82 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis acneiform  1  1/24 (4.17%)  0/82 (0.00%) 
Rash  1  0/24 (0.00%)  3/82 (3.66%) 
Rash generalised  1  0/24 (0.00%)  1/82 (1.22%) 
Rash macular  1  0/24 (0.00%)  1/82 (1.22%) 
Rash maculo-papular  1  0/24 (0.00%)  1/82 (1.22%) 
Skin ulcer  1  0/24 (0.00%)  1/82 (1.22%) 
Vascular disorders     
Embolism  1  0/24 (0.00%)  3/82 (3.66%) 
Hypertension  1  3/24 (12.50%)  4/82 (4.88%) 
Hypotension  1  7/24 (29.17%)  15/82 (18.29%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tablet Only TABLET ONLY
Affected / at Risk (%) Affected / at Risk (%)
Total   24/24 (100.00%)   82/82 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  17/24 (70.83%)  66/82 (80.49%) 
Febrile neutropenia  1  7/24 (29.17%)  30/82 (36.59%) 
Leukopenia  1  3/24 (12.50%)  9/82 (10.98%) 
Neutropenia  1  8/24 (33.33%)  35/82 (42.68%) 
Thrombocytopenia  1  10/24 (41.67%)  40/82 (48.78%) 
Cardiac disorders     
Pericardial effusion  1  0/24 (0.00%)  6/82 (7.32%) 
Sinus bradycardia  1  0/24 (0.00%)  5/82 (6.10%) 
Sinus tachycardia  1  3/24 (12.50%)  16/82 (19.51%) 
Tachycardia  1  10/24 (41.67%)  25/82 (30.49%) 
Ear and labyrinth disorders     
Ear pain  1  4/24 (16.67%)  21/82 (25.61%) 
Eye disorders     
Eye discharge  1  2/24 (8.33%)  0/82 (0.00%) 
Eye pain  1  2/24 (8.33%)  6/82 (7.32%) 
Ocular hyperaemia  1  3/24 (12.50%)  4/82 (4.88%) 
Periorbital oedema  1  3/24 (12.50%)  6/82 (7.32%) 
Vision blurred  1  1/24 (4.17%)  14/82 (17.07%) 
Gastrointestinal disorders     
Abdominal distension  1  3/24 (12.50%)  8/82 (9.76%) 
Abdominal pain  1  16/24 (66.67%)  57/82 (69.51%) 
Abdominal pain upper  1  2/24 (8.33%)  17/82 (20.73%) 
Anal fissure  1  0/24 (0.00%)  5/82 (6.10%) 
Anal inflammation  1  3/24 (12.50%)  4/82 (4.88%) 
Ascites  1  0/24 (0.00%)  5/82 (6.10%) 
Colitis  1  2/24 (8.33%)  11/82 (13.41%) 
Constipation  1  12/24 (50.00%)  46/82 (56.10%) 
Diarrhoea  1  13/24 (54.17%)  62/82 (75.61%) 
Dyschezia  1  2/24 (8.33%)  0/82 (0.00%) 
Dyspepsia  1  1/24 (4.17%)  6/82 (7.32%) 
Enteritis  1  2/24 (8.33%)  0/82 (0.00%) 
Haematochezia  1  2/24 (8.33%)  12/82 (14.63%) 
Mouth ulceration  1  3/24 (12.50%)  5/82 (6.10%) 
Nausea  1  12/24 (50.00%)  69/82 (84.15%) 
Oral pain  1  3/24 (12.50%)  24/82 (29.27%) 
Proctalgia  1  2/24 (8.33%)  13/82 (15.85%) 
Proctitis  1  2/24 (8.33%)  3/82 (3.66%) 
Rectal haemorrhage  1  0/24 (0.00%)  5/82 (6.10%) 
Stomatitis  1  8/24 (33.33%)  41/82 (50.00%) 
Toothache  1  1/24 (4.17%)  8/82 (9.76%) 
Vomiting  1  17/24 (70.83%)  66/82 (80.49%) 
General disorders     
Asthenia  1  0/24 (0.00%)  11/82 (13.41%) 
Catheter site bruise  1  3/24 (12.50%)  0/82 (0.00%) 
Catheter site erythema  1  3/24 (12.50%)  3/82 (3.66%) 
Catheter site pain  1  4/24 (16.67%)  10/82 (12.20%) 
Chills  1  4/24 (16.67%)  16/82 (19.51%) 
Face oedema  1  1/24 (4.17%)  7/82 (8.54%) 
Fatigue  1  13/24 (54.17%)  45/82 (54.88%) 
Gait disturbance  1  4/24 (16.67%)  6/82 (7.32%) 
Influenza like illness  1  0/24 (0.00%)  6/82 (7.32%) 
Malaise  1  0/24 (0.00%)  7/82 (8.54%) 
Mucosal inflammation  1  8/24 (33.33%)  43/82 (52.44%) 
Non-cardiac chest pain  1  3/24 (12.50%)  15/82 (18.29%) 
Oedema  1  1/24 (4.17%)  9/82 (10.98%) 
Oedema peripheral  1  1/24 (4.17%)  16/82 (19.51%) 
Pain  1  3/24 (12.50%)  25/82 (30.49%) 
Pyrexia  1  21/24 (87.50%)  58/82 (70.73%) 
Hepatobiliary disorders     
Hepatomegaly  1  0/24 (0.00%)  5/82 (6.10%) 
Immune system disorders     
Anaphylactic reaction  1  3/24 (12.50%)  1/82 (1.22%) 
Drug hypersensitivity  1  3/24 (12.50%)  14/82 (17.07%) 
Infections and infestations     
Bronchitis  1  2/24 (8.33%)  2/82 (2.44%) 
Candida infection  1  0/24 (0.00%)  11/82 (13.41%) 
Catheter site infection  1  2/24 (8.33%)  1/82 (1.22%) 
Cellulitis  1  1/24 (4.17%)  9/82 (10.98%) 
Clostridium difficile colitis  1  2/24 (8.33%)  9/82 (10.98%) 
Clostridium difficile infection  1  2/24 (8.33%)  6/82 (7.32%) 
Conjunctivitis  1  0/24 (0.00%)  12/82 (14.63%) 
Device related infection  1  1/24 (4.17%)  6/82 (7.32%) 
Ear infection  1  0/24 (0.00%)  7/82 (8.54%) 
Enterocolitis bacterial  1  2/24 (8.33%)  0/82 (0.00%) 
Enterocolitis infectious  1  1/24 (4.17%)  9/82 (10.98%) 
Influenza  1  0/24 (0.00%)  7/82 (8.54%) 
Lung infection  1  2/24 (8.33%)  6/82 (7.32%) 
Mucosal infection  1  0/24 (0.00%)  5/82 (6.10%) 
Oral candidiasis  1  0/24 (0.00%)  14/82 (17.07%) 
Otitis media  1  1/24 (4.17%)  10/82 (12.20%) 
Paronychia  1  2/24 (8.33%)  3/82 (3.66%) 
Pharyngitis  1  1/24 (4.17%)  9/82 (10.98%) 
Pneumonia  1  1/24 (4.17%)  5/82 (6.10%) 
Rhinitis  1  0/24 (0.00%)  11/82 (13.41%) 
Rhinovirus infection  1  1/24 (4.17%)  6/82 (7.32%) 
Sepsis  1  2/24 (8.33%)  5/82 (6.10%) 
Sinusitis  1  1/24 (4.17%)  17/82 (20.73%) 
Skin infection  1  1/24 (4.17%)  11/82 (13.41%) 
Upper respiratory tract infection  1  10/24 (41.67%)  29/82 (35.37%) 
Urinary tract infection  1  2/24 (8.33%)  12/82 (14.63%) 
Viral upper respiratory tract infection  1  3/24 (12.50%)  6/82 (7.32%) 
Injury, poisoning and procedural complications     
Allergic transfusion reaction  1  3/24 (12.50%)  10/82 (12.20%) 
Anal injury  1  2/24 (8.33%)  1/82 (1.22%) 
Arthropod bite  1  2/24 (8.33%)  4/82 (4.88%) 
Contusion  1  8/24 (33.33%)  24/82 (29.27%) 
Skin abrasion  1  2/24 (8.33%)  6/82 (7.32%) 
Sunburn  1  2/24 (8.33%)  5/82 (6.10%) 
Transfusion reaction  1  0/24 (0.00%)  6/82 (7.32%) 
Investigations     
Alanine aminotransferase increased  1  13/24 (54.17%)  29/82 (35.37%) 
Amylase increased  1  2/24 (8.33%)  2/82 (2.44%) 
Aspartate aminotransferase increased  1  12/24 (50.00%)  23/82 (28.05%) 
Blood bilirubin increased  1  1/24 (4.17%)  11/82 (13.41%) 
Blood creatinine increased  1  2/24 (8.33%)  7/82 (8.54%) 
Cardiac murmur  1  1/24 (4.17%)  11/82 (13.41%) 
Electrocardiogram qt prolonged  1  0/24 (0.00%)  6/82 (7.32%) 
Gamma-glutamyltransferase increased  1  2/24 (8.33%)  5/82 (6.10%) 
Lipase increased  1  2/24 (8.33%)  2/82 (2.44%) 
Lymphocyte count decreased  1  3/24 (12.50%)  5/82 (6.10%) 
Neutrophil count decreased  1  10/24 (41.67%)  31/82 (37.80%) 
Platelet count decreased  1  10/24 (41.67%)  29/82 (35.37%) 
Weight decreased  1  4/24 (16.67%)  22/82 (26.83%) 
Weight increased  1  2/24 (8.33%)  9/82 (10.98%) 
White blood cell count decreased  1  5/24 (20.83%)  16/82 (19.51%) 
Metabolism and nutrition disorders     
Decreased appetite  1  9/24 (37.50%)  31/82 (37.80%) 
Dehydration  1  2/24 (8.33%)  12/82 (14.63%) 
Fluid overload  1  0/24 (0.00%)  5/82 (6.10%) 
Hyperglycaemia  1  6/24 (25.00%)  17/82 (20.73%) 
Hypertriglyceridaemia  1  2/24 (8.33%)  3/82 (3.66%) 
Hypoalbuminaemia  1  9/24 (37.50%)  25/82 (30.49%) 
Hypocalcaemia  1  5/24 (20.83%)  25/82 (30.49%) 
Hypoglycaemia  1  2/24 (8.33%)  2/82 (2.44%) 
Hypokalaemia  1  9/24 (37.50%)  41/82 (50.00%) 
Hypomagnesaemia  1  5/24 (20.83%)  14/82 (17.07%) 
Hyponatraemia  1  4/24 (16.67%)  19/82 (23.17%) 
Hypophosphataemia  1  6/24 (25.00%)  17/82 (20.73%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/24 (20.83%)  33/82 (40.24%) 
Back pain  1  8/24 (33.33%)  40/82 (48.78%) 
Bone pain  1  4/24 (16.67%)  18/82 (21.95%) 
Muscle spasms  1  2/24 (8.33%)  3/82 (3.66%) 
Muscular weakness  1  7/24 (29.17%)  14/82 (17.07%) 
Musculoskeletal chest pain  1  0/24 (0.00%)  8/82 (9.76%) 
Musculoskeletal pain  1  2/24 (8.33%)  13/82 (15.85%) 
Myalgia  1  3/24 (12.50%)  12/82 (14.63%) 
Neck pain  1  1/24 (4.17%)  8/82 (9.76%) 
Osteonecrosis  1  0/24 (0.00%)  7/82 (8.54%) 
Pain in extremity  1  12/24 (50.00%)  51/82 (62.20%) 
Pain in jaw  1  1/24 (4.17%)  17/82 (20.73%) 
Nervous system disorders     
Ataxia  1  2/24 (8.33%)  2/82 (2.44%) 
Dizziness  1  0/24 (0.00%)  14/82 (17.07%) 
Headache  1  10/24 (41.67%)  60/82 (73.17%) 
Lethargy  1  1/24 (4.17%)  6/82 (7.32%) 
Neuropathy peripheral  1  1/24 (4.17%)  5/82 (6.10%) 
Peripheral motor neuropathy  1  1/24 (4.17%)  11/82 (13.41%) 
Peripheral sensory neuropathy  1  1/24 (4.17%)  12/82 (14.63%) 
Somnolence  1  0/24 (0.00%)  5/82 (6.10%) 
Tremor  1  1/24 (4.17%)  7/82 (8.54%) 
Psychiatric disorders     
Agitation  1  4/24 (16.67%)  6/82 (7.32%) 
Anxiety  1  4/24 (16.67%)  11/82 (13.41%) 
Depression  1  3/24 (12.50%)  13/82 (15.85%) 
Hallucination  1  2/24 (8.33%)  2/82 (2.44%) 
Insomnia  1  3/24 (12.50%)  13/82 (15.85%) 
Irritability  1  5/24 (20.83%)  7/82 (8.54%) 
Renal and urinary disorders     
Dysuria  1  4/24 (16.67%)  8/82 (9.76%) 
Haematuria  1  2/24 (8.33%)  11/82 (13.41%) 
Urinary retention  1  1/24 (4.17%)  5/82 (6.10%) 
Urinary tract pain  1  2/24 (8.33%)  1/82 (1.22%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  3/24 (12.50%)  5/82 (6.10%) 
Cough  1  15/24 (62.50%)  63/82 (76.83%) 
Dyspnoea  1  4/24 (16.67%)  14/82 (17.07%) 
Epistaxis  1  3/24 (12.50%)  24/82 (29.27%) 
Hypoxia  1  4/24 (16.67%)  11/82 (13.41%) 
Nasal congestion  1  4/24 (16.67%)  24/82 (29.27%) 
Oropharyngeal pain  1  4/24 (16.67%)  31/82 (37.80%) 
Pleural effusion  1  3/24 (12.50%)  13/82 (15.85%) 
Productive cough  1  2/24 (8.33%)  6/82 (7.32%) 
Respiratory tract congestion  1  2/24 (8.33%)  8/82 (9.76%) 
Rhinitis allergic  1  0/24 (0.00%)  8/82 (9.76%) 
Rhinorrhoea  1  13/24 (54.17%)  24/82 (29.27%) 
Sneezing  1  2/24 (8.33%)  5/82 (6.10%) 
Tachypnoea  1  2/24 (8.33%)  9/82 (10.98%) 
Wheezing  1  1/24 (4.17%)  12/82 (14.63%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  2/24 (8.33%)  19/82 (23.17%) 
Dermatitis acneiform  1  0/24 (0.00%)  9/82 (10.98%) 
Dermatitis diaper  1  4/24 (16.67%)  1/82 (1.22%) 
Dry skin  1  3/24 (12.50%)  16/82 (19.51%) 
Ecchymosis  1  3/24 (12.50%)  4/82 (4.88%) 
Eczema  1  2/24 (8.33%)  2/82 (2.44%) 
Erythema  1  4/24 (16.67%)  18/82 (21.95%) 
Hyperhidrosis  1  0/24 (0.00%)  5/82 (6.10%) 
Ingrowing nail  1  0/24 (0.00%)  5/82 (6.10%) 
Pain of skin  1  1/24 (4.17%)  5/82 (6.10%) 
Petechiae  1  3/24 (12.50%)  14/82 (17.07%) 
Pruritus  1  6/24 (25.00%)  21/82 (25.61%) 
Rash  1  11/24 (45.83%)  37/82 (45.12%) 
Rash maculo-papular  1  5/24 (20.83%)  16/82 (19.51%) 
Rash papular  1  2/24 (8.33%)  6/82 (7.32%) 
Swelling face  1  1/24 (4.17%)  8/82 (9.76%) 
Urticaria  1  2/24 (8.33%)  7/82 (8.54%) 
Vascular disorders     
Flushing  1  1/24 (4.17%)  9/82 (10.98%) 
Haematoma  1  2/24 (8.33%)  4/82 (4.88%) 
Hypertension  1  6/24 (25.00%)  35/82 (42.68%) 
Hypotension  1  5/24 (20.83%)  23/82 (28.05%) 
Pallor  1  4/24 (16.67%)  7/82 (8.54%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please email:
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01460160    
Other Study ID Numbers: CA180-372
2011-001123-20 ( EudraCT Number )
AALL1122 ( Other Identifier: COG )
First Submitted: October 25, 2011
First Posted: October 26, 2011
Results First Submitted: May 25, 2018
Results First Posted: August 21, 2018
Last Update Posted: July 8, 2020