Trial Outcomes & Findings for A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemotherapy (NCT NCT01184885)
NCT ID: NCT01184885
Last Updated: 2025-05-04
Results Overview
This will be assessed by evaluating the tolerability of this regimen compared to historical controls who received Hyper-CVAD or Hyper-CVAD/ Rituximab regimens. The treatment will be designated feasible for an individual subject if in 80% of chemotherapy cycles the subject has count recovery that allows for starting the subsequent cycle by Day 28. Count recovery is defined as ANC (absolute neutrophil count) of \> 0.5 x 10\^9/L and platelet count \> 50 x 10\^9/L. Hyper-CVAD/Rapamycin will be deemed acceptable if it is feasible to administer in 80% or more of subjects.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
7 participants
Primary outcome timeframe
18 months
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Hyper-CVAD and Sirolimus
Hyper-CVAD and Sirolimus
Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are \< 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemotherapy
Baseline characteristics by cohort
| Measure |
Hyper-CVAD and Sirolimus
n=7 Participants
Hyper-CVAD and Sirolimus
Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are \< 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
41.68 years
STANDARD_DEVIATION 18.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsThis will be assessed by evaluating the tolerability of this regimen compared to historical controls who received Hyper-CVAD or Hyper-CVAD/ Rituximab regimens. The treatment will be designated feasible for an individual subject if in 80% of chemotherapy cycles the subject has count recovery that allows for starting the subsequent cycle by Day 28. Count recovery is defined as ANC (absolute neutrophil count) of \> 0.5 x 10\^9/L and platelet count \> 50 x 10\^9/L. Hyper-CVAD/Rapamycin will be deemed acceptable if it is feasible to administer in 80% or more of subjects.
Outcome measures
| Measure |
Hyper-CVAD and Sirolimus
n=7 Participants
Hyper-CVAD and Sirolimus
Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m\^2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m\^2 on day 6; Decadron 40mg/day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Cycle B: Methotrexate 1000mg/m\^2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are \< 0.1 umol/L; Ara-C 3000mg/m\^2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Rituximab (if given) will be 375 mg/m\^2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)
|
|---|---|
|
Number of Participants With Count Recovery That Allows for Starting a Phase II Study to Evaluate Response Rates and Survival
|
7 participants
|
SECONDARY outcome
Timeframe: 18 monthsInduction mortality. Hyper-CVAD/ Rapamycin will be considered acceptable if induction mortality does not exceed 31% in patients older than 60, or 15% in those younger than 60
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 21 days or as count recovery allows (at least 14 days apart) up to 24 weeksTo describe response rates to hyper-CVAD and sirolimus in adults with ALL and other aggressive lymphoid malignancies. Bone marrow (\<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL).
Outcome measures
| Measure |
Hyper-CVAD and Sirolimus
n=7 Participants
Hyper-CVAD and Sirolimus
Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m\^2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m\^2 on day 6; Decadron 40mg/day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Cycle B: Methotrexate 1000mg/m\^2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are \< 0.1 umol/L; Ara-C 3000mg/m\^2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Rituximab (if given) will be 375 mg/m\^2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)
|
|---|---|
|
Complete Response
|
4 participants
|
Adverse Events
Hyper-CVAD and Sirolimus
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hyper-CVAD and Sirolimus
n=7 participants at risk
Hyper-CVAD and Sirolimus
Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are \< 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
71.4%
5/7 • Number of events 8
|
|
Infections and infestations
Infection
|
28.6%
2/7 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Edema
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Speech impairment
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypotension
|
28.6%
2/7 • Number of events 2
|
|
Immune system disorders
Gram negative sepsis
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Face pain
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
14.3%
1/7 • Number of events 1
|
|
Immune system disorders
Septic shock
|
14.3%
1/7 • Number of events 1
|
Other adverse events
| Measure |
Hyper-CVAD and Sirolimus
n=7 participants at risk
Hyper-CVAD and Sirolimus
Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are \< 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
* Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)
|
|---|---|
|
General disorders
Shoulder pain
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Abdominal pain
|
57.1%
4/7 • Number of events 5
|
|
General disorders
Weight gain
|
28.6%
2/7 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Edema
|
71.4%
5/7 • Number of events 10
|
|
General disorders
Fatigue
|
100.0%
7/7 • Number of events 15
|
|
General disorders
Constipation
|
28.6%
2/7 • Number of events 4
|
|
General disorders
Extremity swelling
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Itching
|
57.1%
4/7 • Number of events 4
|
|
General disorders
Weakness
|
100.0%
7/7 • Number of events 10
|
|
General disorders
Bad taste in mouth
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Nightmares
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
71.4%
5/7 • Number of events 11
|
|
General disorders
Blood in stool
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
57.1%
4/7 • Number of events 4
|
|
General disorders
Weight loss
|
28.6%
2/7 • Number of events 3
|
|
General disorders
Sweats
|
57.1%
4/7 • Number of events 7
|
|
General disorders
Chest pain
|
57.1%
4/7 • Number of events 6
|
|
General disorders
Opacified left maxillary sinus
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Back pain
|
57.1%
4/7 • Number of events 4
|
|
General disorders
Sinusitis
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Numbness/tingling
|
42.9%
3/7 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle pain/tightness
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Neutropenic fever
|
42.9%
3/7 • Number of events 5
|
|
Blood and lymphatic system disorders
Hyponatremia
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Chills
|
71.4%
5/7 • Number of events 9
|
|
General disorders
Nausea
|
85.7%
6/7 • Number of events 11
|
|
General disorders
Abdominal ascites
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Gingivitis
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Insomnia
|
57.1%
4/7 • Number of events 4
|
|
General disorders
Cough
|
57.1%
4/7 • Number of events 7
|
|
Renal and urinary disorders
Nocturia
|
42.9%
3/7 • Number of events 3
|
|
General disorders
Stiff neck
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Congestion
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
71.4%
5/7 • Number of events 8
|
|
General disorders
Fever
|
71.4%
5/7 • Number of events 9
|
|
Gastrointestinal disorders
Gastric reflux
|
28.6%
2/7 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
85.7%
6/7 • Number of events 12
|
|
General disorders
Vomiting
|
57.1%
4/7 • Number of events 5
|
|
Eye disorders
Blurred vision
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Post nasal drip
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Eye pain
|
14.3%
1/7 • Number of events 2
|
|
General disorders
Nosebleed
|
57.1%
4/7 • Number of events 6
|
|
General disorders
Hypoxia
|
28.6%
2/7 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Lightheadedness
|
28.6%
2/7 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Stomach upset
|
28.6%
2/7 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Abscess
|
28.6%
2/7 • Number of events 2
|
|
Infections and infestations
Infection
|
42.9%
3/7 • Number of events 4
|
|
Nervous system disorders
Neuropathy
|
57.1%
4/7 • Number of events 6
|
|
General disorders
Alopecia
|
57.1%
4/7 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Poor appetite
|
71.4%
5/7 • Number of events 5
|
|
Blood and lymphatic system disorders
Positive blood culture
|
28.6%
2/7 • Number of events 3
|
|
Blood and lymphatic system disorders
Low platelets
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Tooth problem
|
28.6%
2/7 • Number of events 2
|
|
Blood and lymphatic system disorders
Low hemoglobin
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Pulse oxygen dropped
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Mouth sores
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
3/7 • Number of events 4
|
|
Blood and lymphatic system disorders
Hypertension
|
28.6%
2/7 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Facial flushing
|
28.6%
2/7 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
42.9%
3/7 • Number of events 4
|
|
General disorders
Headache
|
57.1%
4/7 • Number of events 9
|
|
General disorders
Speech impairment
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Throat pain
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Double vision
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Unable to move right eye
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Lower abductor pain
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Trouble sleeping
|
42.9%
3/7 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • Number of events 9
|
|
General disorders
Taste alteration
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Hip pain
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Cold
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Groin nodule
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Sinus congestion
|
28.6%
2/7 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperpigmented circumscribed areas on scalp
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Dry eyes
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Respiratory infection
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Bone pain
|
42.9%
3/7 • Number of events 3
|
|
General disorders
Sore throat
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Wrist pain
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Ankle pain
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
28.6%
2/7 • Number of events 3
|
|
Eye disorders
Eye conjunctival redness
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Gas/bloating
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Agitation
|
28.6%
2/7 • Number of events 2
|
|
Psychiatric disorders
Mood alteration
|
28.6%
2/7 • Number of events 2
|
|
Psychiatric disorders
Psychosis
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Rigidity
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Catatonia
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Difficulty swallowing
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Dizziness
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Puffy face
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Swollen ankles
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Blister
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Mouth/throat discomfort
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Rectal pain
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Abnormal gait
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Jaw pain
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Leg pain
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Soft tissue swelling
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Irregular heartbeat
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Achiness
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • Number of events 2
|
|
General disorders
Sinus headache
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Soreness of tongue
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Stomach pain
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Mucositis
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Bleeding from PICC site
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Choreiform movement
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Transfusion reaction
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Decreased urine output
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Lactic acidosis
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Elevated bilirubin
|
14.3%
1/7 • Number of events 2
|
|
Eye disorders
Eyes appear uncoordinated
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Bleeding from IV site
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypokalemia
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Autodiuresis/polyuria
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Fall
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Anal incontinence
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Increased troponins
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Jaundice
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Oral bleeding
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Rib pain
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Decreased bowel sounds
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
28.6%
2/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Absent breath sounds
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Volume overload
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Abdominal tenderness
|
14.3%
1/7 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place