Trial Outcomes & Findings for Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation (NCT NCT03953898)
NCT ID: NCT03953898
Last Updated: 2025-09-10
Results Overview
Will be evaluated by Myelodysplastic Syndrome International Working Group (IWG) 2006 criteria (Cheson et al., 2006) and acute myeloid leukemia (AML) IWG 2003 criteria (Cheson et al., 2003) after 6 cycles of treatment. Cumulative ORR will include complete remission (CR), complete remission with incomplete blood count recovery (CRi), partial response (PR), and bone marrow complete remission (marrow CR) achieved at least at one point during these 6 cycles.
ACTIVE_NOT_RECRUITING
PHASE2
14 participants
Up to 6 cycles
2025-09-10
Participant Flow
Participant milestones
| Measure |
Treatment (Olaparib)
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity, or absence of remission after 6 cycles for patients without prior exposure to IDH inhibitors, or for up to 12 cycles. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration
Olaparib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
Started Therapy
|
12
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Treatment (Olaparib)
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity, or absence of remission after 6 cycles for patients without prior exposure to IDH inhibitors, or for up to 12 cycles. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration
Olaparib: Given PO
|
|---|---|
|
Overall Study
Lack of Efficacy
|
8
|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation
Baseline characteristics by cohort
| Measure |
Treatment (Olaparib)
n=14 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity, or absence of remission after 6 cycles for patients without prior exposure to IDH inhibitors, or for up to 12 cycles. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration
Olaparib: Given PO
|
|---|---|
|
Age, Continuous
|
76 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Latino
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black/African American
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Missing
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
|
ECOG PS
0: Fully active
|
3 Participants
n=5 Participants
|
|
ECOG PS
1: Unable to do strenuous activities
|
9 Participants
n=5 Participants
|
|
ECOG PS
2: Able to walk and manage self-care
|
2 Participants
n=5 Participants
|
|
ECOG PS
3: Confined to bed or a chair more than 50% of waking hours
|
0 Participants
n=5 Participants
|
|
ECOG PS
4: Completely disabled
|
0 Participants
n=5 Participants
|
|
ECOG PS
5: Death
|
0 Participants
n=5 Participants
|
|
IDH mutation
IDH1
|
3 Participants
n=5 Participants
|
|
IDH mutation
IDH2
|
9 Participants
n=5 Participants
|
|
IDH mutation
IDH1 and IDH2
|
1 Participants
n=5 Participants
|
|
IDH mutation
MISSING
|
1 Participants
n=5 Participants
|
|
Prior IDH inhibitor exposure
Yes
|
8 Participants
n=5 Participants
|
|
Prior IDH inhibitor exposure
No
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 cyclesPopulation: Participants receiving treatment
Will be evaluated by Myelodysplastic Syndrome International Working Group (IWG) 2006 criteria (Cheson et al., 2006) and acute myeloid leukemia (AML) IWG 2003 criteria (Cheson et al., 2003) after 6 cycles of treatment. Cumulative ORR will include complete remission (CR), complete remission with incomplete blood count recovery (CRi), partial response (PR), and bone marrow complete remission (marrow CR) achieved at least at one point during these 6 cycles.
Outcome measures
| Measure |
Treatment (Olaparib)
n=12 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity, or absence of remission after 6 cycles for patients without prior exposure to IDH inhibitors, or for up to 12 cycles. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration
Olaparib: Given PO
|
|---|---|
|
Cumulative Overall Response Rate (ORR)
Complete remission (CR)
|
0 Participants
|
|
Cumulative Overall Response Rate (ORR)
Complete remission with incomplete hematologic response
|
0 Participants
|
|
Cumulative Overall Response Rate (ORR)
Complete remission with partial hematologic response
|
0 Participants
|
|
Cumulative Overall Response Rate (ORR)
Composite CR rate (CR+CRi+CRh)
|
0 Participants
|
|
Cumulative Overall Response Rate (ORR)
No Response
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants receiving treatment
The effectiveness of the drug in patients for each cohort will be independently assessed by ORR. The exact two-sided 95% confidence intervals (CI) for the ORR will be reported. The CI based on the Greenwoods variance will be reported.
Outcome measures
| Measure |
Treatment (Olaparib)
n=12 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity, or absence of remission after 6 cycles for patients without prior exposure to IDH inhibitors, or for up to 12 cycles. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration
Olaparib: Given PO
|
|---|---|
|
ORR
OR = Yes
|
0 Participants
|
|
ORR
OR = No
|
12 Participants
|
SECONDARY outcome
Timeframe: From first day of therapy to the time of documentation of progression, death of any cause, or last follow-up, whichever comes first, assessed up to 12 monthsPopulation: Participants receiving treatment
Will be estimated using the Kaplan-Meier method with the 95% CIs. The CI based on the Greenwoods variance will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age and stage of disease on the survival data. The adjusted p-values of the odds ratios and the adjusted 95% confidence interval will be reported.
Outcome measures
| Measure |
Treatment (Olaparib)
n=12 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity, or absence of remission after 6 cycles for patients without prior exposure to IDH inhibitors, or for up to 12 cycles. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration
Olaparib: Given PO
|
|---|---|
|
Progression-free Survival (PFS)
|
2.3 months
Interval 0.4 to 5.6
|
SECONDARY outcome
Timeframe: From first day of therapy to the time of death or last follow-up, whichever comes first, assessed up to 12 monthsPopulation: Participants receiving treatment
Will be estimated using the Kaplan-Meier method with the 95% CIs. The CI based on the Greenwoods variance will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age and stage of disease on the survival data. The adjusted p-values of the odds ratios and the adjusted 95% confidence interval will be reported.
Outcome measures
| Measure |
Treatment (Olaparib)
n=12 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity, or absence of remission after 6 cycles for patients without prior exposure to IDH inhibitors, or for up to 12 cycles. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration
Olaparib: Given PO
|
|---|---|
|
Overall Survival (OS)
|
3.4 months
Interval 0.4 to 35.3
|
SECONDARY outcome
Timeframe: From first documentation of response to the time of documentation of progression, death of any cause, or last follow-up, whichever comes first, assessed up to 12 monthsPopulation: no patients responded to treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 12 pariticipants received treatment.
Non-hematologic toxicity will be evaluated by Common Terminology Criteria for Adverse Events version 5 criteria. Presented are the count of those that experienced at least one non-serious adverse event.
Outcome measures
| Measure |
Treatment (Olaparib)
n=12 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity, or absence of remission after 6 cycles for patients without prior exposure to IDH inhibitors, or for up to 12 cycles. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration
Olaparib: Given PO
|
|---|---|
|
Incidence of Adverse Events
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 monthsThe Mann-Whitney U test will be used to test for differences in post-treatment plasma 2HG concentrations between patients with a response to treatment and those without. Will also test for differences in Delta2HG (defined as pre-treatment minus post-treatment plasma concentration) between patients with a response to treatment and those without. Differences with p =\< 0.05 will be considered significant. The area under the receiver operating characteristic curve (ROC AUC) will be calculated to determine the cutoff value of the Delta2HG difference. The optimal cutoff value will be determined at the point on the ROC curve at (sensitivity + specificity - 1) is maximized.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 monthsWill define MRD based on the variation of the variant allele frequency of the IDH1/2 mutation in the bone marrow of the patients before and during therapy. Will evaluate two different variables: MRD negativity (defined by the absence of detection of the IDH mutant in the sample) and the molecular response (defined by the log reduction of the frequency of the mutant allele). MRD negativity is a qualitative variable and will be reported as a percentage with 95% confidence interval for each time point and mutation. Will compare the different groups using a Chi-Square test. Molecular response is a quantitative variable reported as a median, min and max for each time point and we will use a student t test for the comparison of the different groups.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 monthsWill be estimated using Poisson distribution model as the fraction of positive reads divided by total reads containing a target. The limit of detection will be defined for each mutation as the mean value of IDH1/2 wild-type controls plus three standard deviations.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Olaparib)
Serious adverse events
| Measure |
Treatment (Olaparib)
n=12 participants at risk
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity, or absence of remission after 6 cycles for patients without prior exposure to IDH inhibitors, or for up to 12 cycles. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration
Olaparib: Given PO
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
General disorders
Death NOS
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
Dyspnea
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
3/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Fungemia
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
Hypoxia
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Infections and infestations - Other, specify
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Lung infection
|
33.3%
4/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Gastrointestinal disorders
Mucositis oral
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Cardiac disorders
Myocardial infarction
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
Respiratory failure
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Sepsis
|
33.3%
4/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
Other adverse events
| Measure |
Treatment (Olaparib)
n=12 participants at risk
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity, or absence of remission after 6 cycles for patients without prior exposure to IDH inhibitors, or for up to 12 cycles. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration
Olaparib: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
6/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
4/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Cardiac disorders
Myocardial infarction
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Eye disorders
Vision decreased
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
General disorders
Disease progression
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
General disorders
Fatigue
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
General disorders
Fever
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
General disorders
Flu like symptoms
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
General disorders
Neck edema
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Gastrointestinal disorders
Mucositis oral
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Gastrointestinal disorders
Oral hemorrhage
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Infections & infestations - Other - Sepsis
|
25.0%
3/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Lung infection
|
25.0%
3/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Skin infection
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Urinary tract infection
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Fungemia
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Infections & infestations - Other - Covid-19
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Lip infection
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Infections and infestations
Upper respiratory infection
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Injury, poisoning and procedural complications
Bruising
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
Platelet count decreased
|
41.7%
5/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
Neutrophil count decreased
|
25.0%
3/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
White blood cell decreased
|
25.0%
3/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
ALT increased
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
AST increased
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
Activated PTT prolonged
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
Alkaline phosphatase increased
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
Investigations - Other, specify - Night Sweat
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Investigations
Lymphocyte count decreased
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - Adrenal Cyst
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - Lung Nodule
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Psychiatric disorders
Hallucinations
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Renal and urinary disorders
Chronic kidney disease
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Renal and urinary disorders
Urinary frequency
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Renal and urinary disorders
Urinary retention
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
4/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
3/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
2/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Cellulitis
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Vascular disorders
Hematoma
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Median time from 1st dose to off-study: 74.5 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60