Trial Outcomes & Findings for PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients (NCT NCT00948090)
NCT ID: NCT00948090
Last Updated: 2014-07-31
Results Overview
The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
207 participants
Primary outcome timeframe
2 years
Results posted on
2014-07-31
Participant Flow
A multicenter (43 trial sites in United States and Canada), single-arm, open-label, phase 2 exploratory trial to evaluate clinical outcomes following pharmacokinetic (PK)-directed intravenous (IV) busulfan therapy in 207 participants with Non-Hodgkin's and Hodgkin's lymphoma were evaluated.
Test dose of 0.8 mg/kg of IV busulfan was administered (2-hour continuous infusion) 1 day between Days -14 and -11 for PK analysis to inform subsequent dosing. The conditioning regimen consisted of IV busulfan on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
Participant milestones
| Measure |
Hodgkin's Lymphoma (≤ 65 Years)
Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Hodgkin's Lymphoma (> 65 Years)
Participants with Hodgkins lymphoma whose age was \> 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Non-Hodgkin's Lymphoma (≤ 65 Years)
Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Non-Hodgkin's Lymphoma (> 65 Years)
Participants with Non-Hodgkins lymphoma whose age was \> 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
1
|
123
|
18
|
|
Overall Study
COMPLETED
|
22
|
0
|
67
|
7
|
|
Overall Study
NOT COMPLETED
|
43
|
1
|
56
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients
Baseline characteristics by cohort
| Measure |
Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years)
n=188 Participants
Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Hodgkin's/Non-Hodgkin's Lymphoma (> 65 Years)
n=19 Participants
Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was \> 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Years
|
46.5 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
68.5 Years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the Intent-to-treat (ITT) data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.
The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease.
Outcome measures
| Measure |
Hodgkin's Lymphoma (≤ 65 Years)
n=65 Participants
Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Hodgkin's Lymphoma (> 65 Years)
n=1 Participants
Participants with Hodgkins lymphoma whose age was \> 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Non-Hodgkin's Lymphoma (≤ 65 Years)
n=121 Participants
Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Non-Hodgkin's Lymphoma (> 65 Years)
n=16 Participants
Participants with Non-Hodgkins lymphoma whose age was \> 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
|---|---|---|---|---|
|
Number of Progression Events in 2 Years.
|
41 Event
|
1 Event
|
46 Event
|
8 Event
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.
The time of overall survival was defined as the time from transplantation to death of all causes.
Outcome measures
| Measure |
Hodgkin's Lymphoma (≤ 65 Years)
n=65 Participants
Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Hodgkin's Lymphoma (> 65 Years)
n=1 Participants
Participants with Hodgkins lymphoma whose age was \> 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Non-Hodgkin's Lymphoma (≤ 65 Years)
n=121 Participants
Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Non-Hodgkin's Lymphoma (> 65 Years)
n=16 Participants
Participants with Non-Hodgkins lymphoma whose age was \> 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
|---|---|---|---|---|
|
Number of Death Events in 2 Years.
|
13 Deaths
|
1 Deaths
|
28 Deaths
|
6 Deaths
|
SECONDARY outcome
Timeframe: Day 100Population: Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.
Transplant-related mortality was defined as death due to any cause other than disease relapse/progression up until Day 100.
Outcome measures
| Measure |
Hodgkin's Lymphoma (≤ 65 Years)
n=65 Participants
Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Hodgkin's Lymphoma (> 65 Years)
n=1 Participants
Participants with Hodgkins lymphoma whose age was \> 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Non-Hodgkin's Lymphoma (≤ 65 Years)
n=121 Participants
Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Non-Hodgkin's Lymphoma (> 65 Years)
n=16 Participants
Participants with Non-Hodgkins lymphoma whose age was \> 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
|---|---|---|---|---|
|
Number of Transplant-related Death Events Until Day 100.
|
1 Transplant-related death
|
1 Transplant-related death
|
5 Transplant-related death
|
3 Transplant-related death
|
SECONDARY outcome
Timeframe: Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination)Population: Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.
The overall response status is complete response and not complete response (partial remission, primary refractory/primary induction failure, stable disease, progressive disease, and relapse) at Baseline and each of the scheduled follow-up time points.
Outcome measures
| Measure |
Hodgkin's Lymphoma (≤ 65 Years)
n=65 Participants
Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Hodgkin's Lymphoma (> 65 Years)
n=1 Participants
Participants with Hodgkins lymphoma whose age was \> 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Non-Hodgkin's Lymphoma (≤ 65 Years)
n=121 Participants
Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
Non-Hodgkin's Lymphoma (> 65 Years)
n=16 Participants
Participants with Non-Hodgkins lymphoma whose age was \> 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
|
|---|---|---|---|---|
|
Overall Response Rate
Baseline-Complete Response (N=65, 0, 121, 16)
|
35 Participants
|
0 Participants
|
72 Participants
|
12 Participants
|
|
Overall Response Rate
Baseline-Not Complete Response (N=65, 1, 121, 16)
|
30 Participants
|
1 Participants
|
49 Participants
|
4 Participants
|
|
Overall Response Rate
Day 100-Complete Response (N=57, 0, 114, 12)
|
35 Participants
|
0 Participants
|
85 Participants
|
8 Participants
|
|
Overall Response Rate
Day 100-Not Complete Response (N=57, 0, 114, 12)
|
22 Participants
|
0 Participants
|
29 Participants
|
4 Participants
|
|
Overall Response Rate
Month 6-Complete Response (N=45, 0, 98, 11)
|
30 Participants
|
0 Participants
|
84 Participants
|
9 Participants
|
|
Overall Response Rate
Month 6-Not Complete Response (N=45, 0, 98, 11)
|
15 Participants
|
0 Participants
|
14 Participants
|
2 Participants
|
|
Overall Response Rate
Month 12-Complete Response (N=32, 0, 88, 8)
|
22 Participants
|
0 Participants
|
71 Participants
|
8 Participants
|
|
Overall Response Rate
Month 12-Not Complete Response (N=32, 0, 88, 0)
|
10 Participants
|
0 Participants
|
17 Participants
|
0 Participants
|
|
Overall Response Rate
Month 24-Complete Response (N=13, 0, 28, 6)
|
11 Participants
|
0 Participants
|
26 Participants
|
6 Participants
|
|
Overall Response Rate
Month 24-Not Complete Response (N=13, 0, 28, 0)
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Overall Response Rate
Early Term-Complete Response (N=40, 0, 41, 0)
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Overall Response Rate
Early Term-Not Complete Response (N=40, 0, 41, 5)
|
38 Participants
|
0 Participants
|
37 Participants
|
5 Participants
|
|
Overall Response Rate
End of Trial-Complete Response (N=22, 0, 71, 9)
|
20 Participants
|
0 Participants
|
65 Participants
|
8 Participants
|
|
Overall Response Rate
End of Trial-Not Complete Response(N=22, 0, 71, 9)
|
2 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
Adverse Events
Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years)
Serious events: 90 serious events
Other events: 190 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years)
n=207 participants at risk
The safety data set consisted of all screened participants who had received at least 1 dose of IV busulfan (including PK test dose).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
3/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
9/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.97%
2/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
5/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Cardiac disorders
Atrial thrombosis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Cardiac disorders
Cardiac failure
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Cardiac disorders
Cardiac tamponade
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Cardiac disorders
Pericardial effusion
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Cardiac disorders
Sinus tachycardia
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Endocrine disorders
Diabetes insipidus
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Nausea
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Stomatitis
|
2.9%
6/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Vomiting
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Multi-organ failure
|
0.97%
2/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Pyrexia
|
4.3%
9/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Hepatobiliary disorders
Cholecystits chronic
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Hepatobiliary disorders
Hepatic vein occlusion
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Immune system disorders
Cytokine storm
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Aspergillosis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Bacteraemia
|
0.97%
2/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Bacterial infection
|
0.97%
2/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Bacterial sepsis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
BK virus infection
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Cellulitis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Clostridial infection
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Clostridium Difficile colitis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Cystitis viral
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Influenza
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Lung infection
|
0.97%
2/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Pneumonia
|
4.3%
9/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Pneumonia fungal
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Pulmonary mycosis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Salmonella bacteraemia
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Sepsis
|
3.9%
8/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Septic shock
|
1.9%
4/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Staphylococcal infection
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Syphilis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Urinary tract infection Enterococcal
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Viraemia
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Injury, poisoning and procedural complications
Delayed engraftment
|
0.97%
2/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Injury, poisoning and procedural complications
Fall
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
Blood culture positive
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
Pulmonary physical examination abnormal
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
4/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Nervous system disorders
Vocal cord paralysis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Psychiatric disorders
Delirium
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Renal and urinary disorders
Haematuria
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Renal and urinary disorders
Renal failure
|
0.97%
2/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Renal and urinary disorders
Renal failure acute
|
2.9%
6/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.97%
2/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.97%
2/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
4/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Vascular disorders
Hypotension
|
3.4%
7/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Vascular disorders
Hypovolaemic shock
|
0.48%
1/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
Other adverse events
| Measure |
Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years)
n=207 participants at risk
The safety data set consisted of all screened participants who had received at least 1 dose of IV busulfan (including PK test dose).
|
|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
22.2%
46/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Blood and lymphatic system disorders
Anaemia
|
10.6%
22/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
62.3%
129/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
23/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.0%
27/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Cardiac disorders
Atrial fibrillation
|
5.8%
12/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Cardiac disorders
Sinus tachycardia
|
5.8%
12/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Cardiac disorders
Tachycardia
|
18.8%
39/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Eye disorders
Dry eye
|
5.8%
12/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Abdominal distension
|
9.2%
19/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Abdominal pain
|
29.5%
61/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.8%
14/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Constipation
|
33.8%
70/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Diarrhoea
|
86.5%
179/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Dry mouth
|
14.5%
30/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Dysphagia
|
9.2%
19/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.2%
19/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Haemorrhoids
|
17.9%
37/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Nausea
|
81.6%
169/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Oesophagitis
|
8.7%
18/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
23/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Proctalgia
|
9.2%
19/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Stomatitis
|
82.1%
170/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Gastrointestinal disorders
Vomiting
|
63.8%
132/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Asthenia
|
13.5%
28/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Catheter site erythema
|
5.8%
12/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Chest discomfort
|
5.8%
12/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Chest pain
|
8.7%
18/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Chills
|
18.4%
38/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Fatigue
|
50.2%
104/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Mucosal inflammation
|
5.3%
11/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Oedema
|
9.7%
20/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Oedema peripheral
|
32.9%
68/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Pain
|
15.0%
31/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
General disorders
Pyrexia
|
45.4%
94/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
9.2%
19/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Oral candidiasis
|
6.3%
13/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Pneumonia
|
5.8%
12/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Infections and infestations
Upper respiratory tract infection
|
10.1%
21/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.3%
11/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
Alanine aminotransferase increased
|
12.1%
25/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
Aspartate aminotransferase increased
|
14.0%
29/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
Blood alkaline phosphatase increased
|
8.7%
18/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
Blood bilirubin increased
|
6.3%
13/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
Blood creatinine increased
|
7.2%
15/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.3%
11/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
Haemoglobin decreased
|
6.3%
13/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
Platelet count decreased
|
9.2%
19/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
Weight decreased
|
15.5%
32/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Investigations
White blood cell count decreased
|
9.2%
19/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
45.4%
94/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Dehydration
|
6.3%
13/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Fluid overload
|
10.6%
22/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.6%
26/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.1%
23/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.6%
26/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
48.3%
100/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
30.4%
63/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
17.4%
36/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
23.2%
48/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
13/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.6%
22/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.2%
15/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
18/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Nervous system disorders
Dizziness
|
20.3%
42/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Nervous system disorders
Dysguesia
|
18.8%
39/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Nervous system disorders
Headache
|
35.3%
73/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Nervous system disorders
Neuropathy peripheral
|
7.7%
16/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Psychiatric disorders
Anxiety
|
24.6%
51/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Psychiatric disorders
Confusional state
|
8.2%
17/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Psychiatric disorders
Depression
|
10.1%
21/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Psychiatric disorders
Hallucination
|
7.7%
16/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Psychiatric disorders
Insomnia
|
41.5%
86/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Renal and urinary disorders
Dysuria
|
9.2%
19/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Renal and urinary disorders
Haematuria
|
7.2%
15/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Renal and urinary disorders
Urinary retention
|
5.3%
11/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.9%
64/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.2%
46/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.8%
14/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.8%
43/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.2%
17/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.2%
17/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.7%
20/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.0%
31/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.8%
14/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.8%
12/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.2%
17/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.3%
11/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.2%
19/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.8%
14/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
17.4%
36/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.8%
14/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
13.0%
27/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.8%
70/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.8%
12/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
7.2%
15/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Vascular disorders
Flushing
|
7.2%
15/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Vascular disorders
Hypertension
|
8.2%
17/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
|
Vascular disorders
Hypotension
|
25.1%
52/207 • Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place