Trial Outcomes & Findings for Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia (NCT NCT02484430)
NCT ID: NCT02484430
Last Updated: 2025-03-03
Results Overview
Complete response rate, defined to be a complete hematologic response (CR) or complete response incomplete (CRi) noted as the objective status at any time during treatment. A CR is defined as having less than 5% blasts in a non-hypocellular marrow with a granulocyte count of 1 x109/L (or above), and a platelet count of 100 x109/L (or higher) and absence of peripheral blood blasts with complete resolution of any extra medullary disease. A patient is defined as having a CRi if they meet all CR criteria except for residual neutropenia (ANC\<1 x109/L) or thrombocytopenia (platelets\<100 x109/L). A CR or CRi will be considered synonymous with "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent exact binomial confidence intervals for the true success proportion will be calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
61 days
Results posted on
2025-03-03
Participant Flow
Participant milestones
| Measure |
Treatment (Sapanisertib)
Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Sapanisertib)
n=16 Participants
Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
45.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 61 daysPopulation: All patients registered and evaluated for a response were included in this analysis. One patient registered but cancelled prior to treatment.
Complete response rate, defined to be a complete hematologic response (CR) or complete response incomplete (CRi) noted as the objective status at any time during treatment. A CR is defined as having less than 5% blasts in a non-hypocellular marrow with a granulocyte count of 1 x109/L (or above), and a platelet count of 100 x109/L (or higher) and absence of peripheral blood blasts with complete resolution of any extra medullary disease. A patient is defined as having a CRi if they meet all CR criteria except for residual neutropenia (ANC\<1 x109/L) or thrombocytopenia (platelets\<100 x109/L). A CR or CRi will be considered synonymous with "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent exact binomial confidence intervals for the true success proportion will be calculated.
Outcome measures
| Measure |
Treatment (Sapanisertib)
n=15 Participants
Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Complete Response (CR or CRi)
|
0 proportion of participants
Interval 0.0 to 0.22
|
SECONDARY outcome
Timeframe: 61 daysPopulation: All patients who registered and began protocol treatment were included in this analysis. One patient registered but cancelled prior to treatment.
ORR will be estimated by the total number of complete or partial responses (CR, CRi or PR), or morphologic leukemia free state \[MLFS\]) divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. A CR is defined as having less than 5% blasts in a non-hypocellular marrow with a granulocyte count of 1 x109/L (or above), and a platelet count of 100 x109/L (or higher) and absence of peripheral blood blasts with complete resolution of any extra medullary disease. A patient is defined as having a CRi if they meet all CR criteria except for residual neutropenia (ANC\<1 x109/L) or thrombocytopenia (platelets\<100 x109/L). A Partial Response (PR) is defined as the presence of trilineage hematopoiesis in the bone marrow with recovery of ANC and platelet count to above levels, but with 5-25% bone marrow blasts and ≥50% decrease in bone marrow blast percentage from baseline.
Outcome measures
| Measure |
Treatment (Sapanisertib)
n=15 Participants
Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response
|
0 proportion of participants
Interval 0.0 to 0.22
|
SECONDARY outcome
Timeframe: 0 daysPopulation: Only patients who achieved a complete response were eligible for this endpoint.
The distribution of duration of complete response will be estimated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 daysPopulation: Patients reporting a CR, CRi, PR or MLFS were eligible for this endpoint. No patients were analyzed because no patients achieved CR, CRi, PR or MLFS.
The frequency is estimated by the number of patients who proceed to allogeneic SCT after achieving response divided by the total number of evaluable patients who achieved a response. All evaluable patients who achieved a response will be used for this analysis. Exact binomial 95% confidence intervals for the true overall response rate will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 23 monthsPopulation: All patients registered and treated per protocol were included in this analysis.
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Sapanisertib)
n=15 Participants
Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
62.0 days
Interval 51.0 to 155.0
|
SECONDARY outcome
Timeframe: 91 daysPopulation: All participants who registered and started protocol treatment were included in this analysis.
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. For this endpoint, we are reporting the maximum grade adverse event per patient.
Outcome measures
| Measure |
Treatment (Sapanisertib)
n=15 Participants
Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Incidence of Adverse Events, Measured Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4
Grade 3
|
0 Participants
|
|
Incidence of Adverse Events, Measured Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4
Grade 4
|
13 Participants
|
|
Incidence of Adverse Events, Measured Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4
Grade 5
|
2 Participants
|
Adverse Events
Treatment (Sapanisertib)
Serious events: 9 serious events
Other events: 15 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Sapanisertib)
n=16 participants at risk
Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
General disorders
Death NOS
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Infections and infestations
Sepsis
|
18.8%
3/16 • Number of events 3 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
6.2%
1/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Nervous system disorders
Intracranial hemorrhage
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Psychiatric disorders
Confusion
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Psychiatric disorders
Delirium
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
Other adverse events
| Measure |
Treatment (Sapanisertib)
n=16 participants at risk
Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
56.2%
9/16 • Number of events 37 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Cardiac disorders
Sinus bradycardia
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
2/16 • Number of events 4 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Cardiac disorders
Supraventricular tachycardia
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
3/16 • Number of events 3 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Anal mucositis
|
6.2%
1/16 • Number of events 3 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Ascites
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Constipation
|
18.8%
3/16 • Number of events 3 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
3/16 • Number of events 4 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Esophagitis
|
6.2%
1/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
2/16 • Number of events 3 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
General disorders
Edema limbs
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
General disorders
Facial pain
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
General disorders
Fatigue
|
37.5%
6/16 • Number of events 9 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
General disorders
Gait disturbance
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Hepatobiliary disorders
Cholecystitis
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Hepatobiliary disorders
Hepatic failure
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Infections and infestations
Lung infection
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
Activated partial throm time prolonged
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
Alanine aminotransferase increased
|
18.8%
3/16 • Number of events 5 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
Aspartate aminotransferase increased
|
18.8%
3/16 • Number of events 3 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
Blood bilirubin increased
|
18.8%
3/16 • Number of events 4 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
Creatinine increased
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
Fibrinogen decreased
|
6.2%
1/16 • Number of events 5 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
INR increased
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
4/16 • Number of events 7 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
Neutrophil count decreased
|
31.2%
5/16 • Number of events 9 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
Platelet count decreased
|
43.8%
7/16 • Number of events 26 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
Weight loss
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Investigations
White blood cell decreased
|
25.0%
4/16 • Number of events 7 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.2%
5/16 • Number of events 7 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
4/16 • Number of events 8 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
2/16 • Number of events 5 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.8%
3/16 • Number of events 6 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
2/16 • Number of events 3 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.8%
3/16 • Number of events 4 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.2%
1/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 4 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Nervous system disorders
Lethargy
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Nervous system disorders
Paresthesia
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Nervous system disorders
Seizure
|
6.2%
1/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16 • Number of events 3 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Renal and urinary disorders
Bladder spasm
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Renal and urinary disorders
Hematuria
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Renal and urinary disorders
Urinary urgency
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
4/16 • Number of events 4 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
4/16 • Number of events 4 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Vascular disorders
Capillary leak syndrome
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 1 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
|
Vascular disorders
Hypotension
|
12.5%
2/16 • Number of events 2 • All cause mortality was followed for 23 months and adverse events were followed for 6 months.
All patients were included in this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60