Trial Outcomes & Findings for IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients (NCT NCT01009840)
NCT ID: NCT01009840
Last Updated: 2026-05-13
Results Overview
The percentage of participants reported in each disease category by International Myeloma Working Group (IMWG) uniform response criteria for Multiple Myeloma 6 months after autologous Hematopoietic stem cell transplant. Overall Disease Response categories were: \[stringent Complete Response (sCR)=CR + normal Free Light Chain (FLC) ratio + absence of clonal cells in bone marrow\], \[Complete Response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow\], \[Very Good Partial Response (VGPR)=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein + urine M-protein level \<100 mg/24 hour\], \[Partial Response (PR)=≥50% reduction of serum M-protein and reduction in 24 hour urine M-protein by ≥90% or to \<200 mg per 24 hour\], \[Stable Disease (SD)=Not meeting criteria for CR, VGPR, PR or progressive disease\] or \[Progressive Disease (PD)\].
COMPLETED
PHASE2
30 participants
6 Months
2026-05-13
Participant Flow
Participant milestones
| Measure |
IV Busulfan
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the pharmacokinetic (PK)-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to hematopoietic stem cell transplant (HSCT).
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
IV Busulfan
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the pharmacokinetic (PK)-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to hematopoietic stem cell transplant (HSCT).
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Subject Met Withdrawal Criteria
|
7
|
|
Overall Study
Subject was Withdrawn by Investigator
|
1
|
|
Overall Study
Subject Withdrew Consent to Participate
|
1
|
Baseline Characteristics
IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients
Baseline characteristics by cohort
| Measure |
IV Busulfan
n=30 Participants
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 6.9 • n=1512 Participants
|
|
Sex/Gender, Customized
Female
|
5 Participants
n=1512 Participants
|
|
Sex/Gender, Customized
Male
|
25 Participants
n=1512 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.
The percentage of participants reported in each disease category by International Myeloma Working Group (IMWG) uniform response criteria for Multiple Myeloma 6 months after autologous Hematopoietic stem cell transplant. Overall Disease Response categories were: \[stringent Complete Response (sCR)=CR + normal Free Light Chain (FLC) ratio + absence of clonal cells in bone marrow\], \[Complete Response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow\], \[Very Good Partial Response (VGPR)=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein + urine M-protein level \<100 mg/24 hour\], \[Partial Response (PR)=≥50% reduction of serum M-protein and reduction in 24 hour urine M-protein by ≥90% or to \<200 mg per 24 hour\], \[Stable Disease (SD)=Not meeting criteria for CR, VGPR, PR or progressive disease\] or \[Progressive Disease (PD)\].
Outcome measures
| Measure |
IV Busulfan
n=30 Participants
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Percentage of Participants With Overall Disease Response at Month 6
sCR or CR or VGPR
|
20.0 Percentage of participants
|
|
Percentage of Participants With Overall Disease Response at Month 6
PR or SD or PD
|
70.0 Percentage of participants
|
|
Percentage of Participants With Overall Disease Response at Month 6
Not Assessed
|
10.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.
Esimated overall survival rate (percentage of participants) at Day 180
Outcome measures
| Measure |
IV Busulfan
n=30 Participants
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Overall Survival
|
85.9 percentage of participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.
Overall Survival Event was death.
Outcome measures
| Measure |
IV Busulfan
n=30 Participants
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Percentage of Participants With Overall Survival Events
|
13.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.
Progression-free Survival (PFS) defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease (PD) by IMWG criteria. PD was defined as an Increase of ≥25% from the lowest response value in any one or more of the following: 1)Serum M-component and/or (the absolute increase must be ≥0.5 g/dL), 2)Urine M-component and/or (the absolute increase must be ≥200 mg/24 hr), 3)In patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \>10 mg/dL, 4)Bone marrow plasma cell percentage; the absolute percentage must be ≥10%, 5)Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas and/or 6)Development of hypercalcaemia that can be attributed solely to the plasma cell proliferative diso
Outcome measures
| Measure |
IV Busulfan
n=30 Participants
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Progression-free Survival
|
191 Days
Interval 92.0 to
The upper limit of the 95% CI could not be estimated. Follow-up was restricted to 6 months post transplant.
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.
Progression-free survival events are death or first recurrence of progressive disease by International Myeloma Working Group Criteria.
Outcome measures
| Measure |
IV Busulfan
n=30 Participants
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Percentage of Participants With Progression-free Survival Events
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day -12 to -9), Day -5Population: Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.
The percent change in dose is relative to the busulfan dose administered at the Baseline Visit (Day -12 to -9) when a dose of 0.8 mg/kg was administered and on Day -5 when the Seattle Cancer Care Alliance recommended PK-adjusted dose was administered.
Outcome measures
| Measure |
IV Busulfan
n=30 Participants
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Percent Change in IV Busulfan Dose
|
7.55 Percent change
Interval -26.0 to 47.5
|
SECONDARY outcome
Timeframe: Baseline (Day -12 to -9), Day -5Population: Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.
A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day -12 to -9) to verify a target busulfan integrated AUC of 20,000 μM\*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. Gas chromatography with mass selective detection (GC-MS) was used to determine the busulfan level in plasma. The ratio was calculated: AUC/Target AUC.
Outcome measures
| Measure |
IV Busulfan
n=30 Participants
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Ratio Area Under Curve (AUC)/Target AUC
|
1.00 Ratio
Interval 0.89 to 1.19
|
SECONDARY outcome
Timeframe: Baseline (Day -12 to -9), Day -5Population: Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.
A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day -12 to -9) to verify a target busulfan integrated AUC of 20,000 μM\*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. GC-MS was used to determine the busulfan level in plasma. The percent difference was calculated between AUC and the Target AUC.
Outcome measures
| Measure |
IV Busulfan
n=30 Participants
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Percent Difference Between Area Under Curve (AUC) and Target AUC
|
-0.22 Percent difference
Interval -10.97 to 18.55
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Safety population included all participants who received IV busulfan.
The percentage of participants with death related to transplant.
Outcome measures
| Measure |
IV Busulfan
n=30 Participants
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Percentage of Participants With Transplant-Related Mortality
|
3.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Safety population included all participants who received IV busulfan.
The Baltimore criteria for veno-occlusive disease was defined as the development of hyperbilirubinemia with serum bilirubin \> 2 mg/dl within 21 days after transplantation and at least 2 of the following clinical signs and symptoms: (1) hepatomegaly, usually painful, (2) \> 5% weight gain, or (3) ascites.
Outcome measures
| Measure |
IV Busulfan
n=30 Participants
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Percentage of Participants With Hepatic Veno-Occlusive Disease Based on Baltimore Criteria
|
0.0 Percentage of participants
|
Adverse Events
IV Busulfan
Serious adverse events
| Measure |
IV Busulfan
n=30 participants at risk
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Renal and urinary disorders
Renal failure acute
|
6.7%
2/30
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.3%
1/30
|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
1/30
|
|
Vascular disorders
Venoocclusive disease
|
3.3%
1/30
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
1/30
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
5/30
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30
|
|
General disorders
Multi-organ failure
|
3.3%
1/30
|
|
General disorders
Pyrexia
|
10.0%
3/30
|
|
Infections and infestations
Bacterial sepsis
|
3.3%
1/30
|
|
Infections and infestations
Bronchitis bacterial
|
3.3%
1/30
|
|
Infections and infestations
Device related infection
|
3.3%
1/30
|
|
Infections and infestations
Septic shock
|
3.3%
1/30
|
|
Infections and infestations
Tinea versicolour
|
3.3%
1/30
|
|
Infections and infestations
Viral infection
|
3.3%
1/30
|
|
Nervous system disorders
Cranial neuropathy
|
3.3%
1/30
|
|
Nervous system disorders
Headache
|
3.3%
1/30
|
|
Renal and urinary disorders
Renal failure
|
3.3%
1/30
|
Other adverse events
| Measure |
IV Busulfan
n=30 participants at risk
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
2/30
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
56.7%
17/30
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
2/30
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
2/30
|
|
Cardiac disorders
Palpitations
|
13.3%
4/30
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
2/30
|
|
Cardiac disorders
Tachycardia
|
16.7%
5/30
|
|
Eye disorders
Dry eye
|
6.7%
2/30
|
|
Eye disorders
Vision blurred
|
10.0%
3/30
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
2/30
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
2/30
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
4/30
|
|
Gastrointestinal disorders
Anal inflammation
|
6.7%
2/30
|
|
Gastrointestinal disorders
Constipation
|
43.3%
13/30
|
|
Gastrointestinal disorders
Diarrhoea
|
86.7%
26/30
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
4/30
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
6/30
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
3/30
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
3/30
|
|
Gastrointestinal disorders
Hematochezia
|
10.0%
3/30
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
3/30
|
|
Gastrointestinal disorders
Nausea
|
80.0%
24/30
|
|
Gastrointestinal disorders
Odynophagia
|
6.7%
2/30
|
|
Gastrointestinal disorders
Oesophagitis
|
6.7%
2/30
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
3/30
|
|
Gastrointestinal disorders
Stomatitis
|
93.3%
28/30
|
|
Gastrointestinal disorders
Vomiting
|
43.3%
13/30
|
|
General disorders
Asthenia
|
16.7%
5/30
|
|
General disorders
Chest pain
|
10.0%
3/30
|
|
General disorders
Chills
|
23.3%
7/30
|
|
General disorders
Fatigue
|
66.7%
20/30
|
|
General disorders
Oedema
|
10.0%
3/30
|
|
General disorders
Oedema peripheral
|
33.3%
10/30
|
|
General disorders
Pyrexia
|
43.3%
13/30
|
|
Infections and infestations
Bacterial infection
|
6.7%
2/30
|
|
Infections and infestations
Bronchitis
|
6.7%
2/30
|
|
Infections and infestations
Candidiasis
|
6.7%
2/30
|
|
Infections and infestations
Clostridial infection
|
6.7%
2/30
|
|
Infections and infestations
Device related infection
|
6.7%
2/30
|
|
Infections and infestations
Pneumonia
|
13.3%
4/30
|
|
Infections and infestations
Sepsis
|
6.7%
2/30
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
2/30
|
|
Injury, poisoning and procedural complications
Excoriation
|
6.7%
2/30
|
|
Injury, poisoning and procedural complications
Skin laceration
|
10.0%
3/30
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
3/30
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
4/30
|
|
Investigations
Blood calcium decreased
|
6.7%
2/30
|
|
Investigations
Blood creatinine increased
|
13.3%
4/30
|
|
Investigations
Blood glucose increased
|
6.7%
2/30
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.0%
3/30
|
|
Investigations
Blood potassium decreased
|
6.7%
2/30
|
|
Investigations
International normalised ratio increased
|
6.7%
2/30
|
|
Investigations
Neutrophil count decreased
|
6.7%
2/30
|
|
Investigations
Weight decreased
|
26.7%
8/30
|
|
Investigations
White blood cell count decreased
|
6.7%
2/30
|
|
Metabolism and nutrition disorders
Decreased appetite
|
56.7%
17/30
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
4/30
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
6/30
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
10.0%
3/30
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.3%
4/30
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.3%
4/30
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
15/30
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
6/30
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
3/30
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.0%
6/30
|
|
Metabolism and nutrition disorders
Malnutrition
|
6.7%
2/30
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.7%
8/30
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
2/30
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.3%
4/30
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
2/30
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
2/30
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
6/30
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.7%
2/30
|
|
Nervous system disorders
Dizziness
|
30.0%
9/30
|
|
Nervous system disorders
Dysgeusia
|
30.0%
9/30
|
|
Nervous system disorders
Headache
|
30.0%
9/30
|
|
Nervous system disorders
Memory impairment
|
6.7%
2/30
|
|
Nervous system disorders
Neuropathy peripheral
|
20.0%
6/30
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
2/30
|
|
Nervous system disorders
Sinus headache
|
6.7%
2/30
|
|
Nervous system disorders
Somnolence
|
6.7%
2/30
|
|
Psychiatric disorders
Anxiety
|
16.7%
5/30
|
|
Psychiatric disorders
Confusional state
|
10.0%
3/30
|
|
Psychiatric disorders
Depression
|
10.0%
3/30
|
|
Psychiatric disorders
Hallucination
|
13.3%
4/30
|
|
Psychiatric disorders
Insomnia
|
23.3%
7/30
|
|
Renal and urinary disorders
Dysuria
|
13.3%
4/30
|
|
Renal and urinary disorders
Haematuria
|
6.7%
2/30
|
|
Renal and urinary disorders
Renal failure
|
10.0%
3/30
|
|
Renal and urinary disorders
Renal failure acute
|
10.0%
3/30
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
2/30
|
|
Reproductive system and breast disorders
Scrotal erythema
|
6.7%
2/30
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.7%
11/30
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.0%
3/30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
6/30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
16.7%
5/30
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
5/30
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
3/30
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.3%
4/30
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
10.0%
3/30
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.3%
4/30
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
10/30
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
13.3%
4/30
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
2/30
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
3/30
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
6/30
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
6/30
|
|
Skin and subcutaneous tissue disorders
Erythema
|
13.3%
4/30
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
4/30
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.7%
8/30
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
10.0%
3/30
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
20.0%
6/30
|
|
Vascular disorders
Flushing
|
13.3%
4/30
|
|
Vascular disorders
Hypertension
|
13.3%
4/30
|
|
Vascular disorders
Hypotension
|
23.3%
7/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place