Trial Outcomes & Findings for American Trial Using Tranexamic Acid in Thrombocytopenia (NCT NCT02578901)
NCT ID: NCT02578901
Last Updated: 2021-03-24
Results Overview
Proportion of patients with bleeding of WHO grade 2 or above, over the study period of 30 days after activation of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
330 participants
Primary outcome timeframe
30 days after activation of study drug
Results posted on
2021-03-24
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid (TXA)
IV or PO administered after meeting inclusion/exclusion criteria
Tranexamic Acid: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered
|
Placebo
IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria
Placebo: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
165
|
|
Overall Study
COMPLETED
|
145
|
144
|
|
Overall Study
NOT COMPLETED
|
20
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
American Trial Using Tranexamic Acid in Thrombocytopenia
Baseline characteristics by cohort
| Measure |
Tranexamic Acid (TXA)
n=165 Participants
IV or PO administered after meeting inclusion/exclusion criteria
Tranexamic Acid: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered
|
Placebo
n=165 Participants
IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria
Placebo: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
141 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after activation of study drugProportion of patients with bleeding of WHO grade 2 or above, over the study period of 30 days after activation of study drug.
Outcome measures
| Measure |
Tranexamic Acid (TXA)
n=145 Participants
IV or PO administered after meeting inclusion/exclusion criteria
Tranexamic Acid: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered
|
Placebo
n=144 Participants
IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria
Placebo: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered
|
|---|---|---|
|
Bleeding Within 30 Days
|
73 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 30 days after activation of study drugNumber of platelet transfusions per patient during the first 30 days post prescription activation of study drug
Outcome measures
| Measure |
Tranexamic Acid (TXA)
n=165 Participants
IV or PO administered after meeting inclusion/exclusion criteria
Tranexamic Acid: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered
|
Placebo
n=165 Participants
IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria
Placebo: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered
|
|---|---|---|
|
Number of Platelet Transfusions
|
7.7 platelet transfusions
Standard Deviation 8.7
|
7.6 platelet transfusions
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: during the first 30 days post activation of study drugNumber of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug
Outcome measures
| Measure |
Tranexamic Acid (TXA)
n=136 Participants
IV or PO administered after meeting inclusion/exclusion criteria
Tranexamic Acid: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered
|
Placebo
n=132 Participants
IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria
Placebo: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered
|
|---|---|---|
|
Number of Days Alive and Without WHO Grade 2 Bleeding
|
28.1 days
Standard Deviation 3.7
|
27.7 days
Standard Deviation 4.7
|
Adverse Events
Tranexamic Acid (TXA)
Serious events: 123 serious events
Other events: 161 other events
Deaths: 19 deaths
Placebo
Serious events: 110 serious events
Other events: 161 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Tranexamic Acid (TXA)
n=163 participants at risk
IV or PO administered after meeting inclusion/exclusion criteria
Tranexamic Acid: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered
|
Placebo
n=163 participants at risk
IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria
Placebo: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
24.5%
40/163 • 120 days after activation
|
22.1%
36/163 • 120 days after activation
|
|
Blood and lymphatic system disorders
Other blood/lymph disorder
|
1.2%
2/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Cardiac disorders
Sinus tachycardia
|
6.1%
10/163 • 120 days after activation
|
5.5%
9/163 • 120 days after activation
|
|
Cardiac disorders
Other cardiac
|
1.8%
3/163 • 120 days after activation
|
2.5%
4/163 • 120 days after activation
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
2/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Cardiac disorders
Atrial flutter
|
1.2%
2/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Cardiac disorders
Cardiac arrest
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Cardiac disorders
Heart failure
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Cardiac disorders
Palpitations
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Cardiac disorders
RV dysfunction
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Cardiac disorders
Sinus bradycardia
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Cardiac disorders
Mitral valve disease
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Cardiac disorders
Tricuspid valve disease
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Congenital, familial and genetic disorders
Other congenital
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Ear and labyrinth disorders
Ear pain
|
1.2%
2/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Ear and labyrinth disorders
Other
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Eye disorders
Blurred vision
|
0.61%
1/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Eye disorders
Other eye disorder
|
1.2%
2/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Eye disorders
Eye pain
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Gastrointestinal disorders
Nausea
|
16.6%
27/163 • 120 days after activation
|
9.8%
16/163 • 120 days after activation
|
|
Gastrointestinal disorders
Diarrhea
|
4.9%
8/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
8/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
9/163 • 120 days after activation
|
4.3%
7/163 • 120 days after activation
|
|
Gastrointestinal disorders
Constipation
|
6.1%
10/163 • 120 days after activation
|
2.5%
4/163 • 120 days after activation
|
|
Gastrointestinal disorders
Other gastrointestinal
|
2.5%
4/163 • 120 days after activation
|
3.7%
6/163 • 120 days after activation
|
|
Gastrointestinal disorders
Mucositis oral
|
2.5%
4/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
2/163 • 120 days after activation
|
3.1%
5/163 • 120 days after activation
|
|
Gastrointestinal disorders
Dysphagia
|
1.2%
2/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Gastrointestinal disorders
Esophageal pain
|
1.2%
2/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Gastrointestinal disorders
Rectal pain
|
2.5%
4/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
3/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Gastrointestinal disorders
Ascites
|
0.61%
1/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Gastrointestinal disorders
Bloating
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.2%
2/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Gastrointestinal disorders
Typhlitis
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Gastrointestinal disorders
Gastroesoph reflux disease
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
General disorders
Fatigue
|
10.4%
17/163 • 120 days after activation
|
9.2%
15/163 • 120 days after activation
|
|
General disorders
Fever
|
7.4%
12/163 • 120 days after activation
|
7.4%
12/163 • 120 days after activation
|
|
General disorders
Edema limbs
|
4.3%
7/163 • 120 days after activation
|
8.0%
13/163 • 120 days after activation
|
|
General disorders
Infusion related reaction
|
1.8%
3/163 • 120 days after activation
|
3.1%
5/163 • 120 days after activation
|
|
General disorders
Other general disorder
|
1.8%
3/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
General disorders
Pain
|
0.61%
1/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
General disorders
Chills
|
0.00%
0/163 • 120 days after activation
|
2.5%
4/163 • 120 days after activation
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/163 • 120 days after activation
|
2.5%
4/163 • 120 days after activation
|
|
General disorders
Multi-organ failure
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
General disorders
Edema face
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
General disorders
Malaise
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
General disorders
Neck edema
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
General disorders
Facial pain
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Hepatobiliary disorders
Other hepatobiliary
|
1.2%
2/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Immune system disorders
Other immune disorder
|
11.0%
18/163 • 120 days after activation
|
7.4%
12/163 • 120 days after activation
|
|
Immune system disorders
Allergic reaction
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Infections and infestations
Other infection
|
11.7%
19/163 • 120 days after activation
|
13.5%
22/163 • 120 days after activation
|
|
Infections and infestations
Sepsis
|
3.1%
5/163 • 120 days after activation
|
6.1%
10/163 • 120 days after activation
|
|
Infections and infestations
Lung infection
|
1.2%
2/163 • 120 days after activation
|
4.9%
8/163 • 120 days after activation
|
|
Infections and infestations
Sinusitis
|
1.8%
3/163 • 120 days after activation
|
3.1%
5/163 • 120 days after activation
|
|
Infections and infestations
Upper respiratory infection
|
2.5%
4/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Infections and infestations
Urinary tract infection
|
2.5%
4/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Infections and infestations
Skin infection
|
1.2%
2/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Infections and infestations
Meningitis
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Infections and infestations
Catheter related infection
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
4/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Injury, poisoning and procedural complications
Other injury
|
1.8%
3/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Injury, poisoning and procedural complications
Bruising
|
1.8%
3/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Injury, poisoning and procedural complications
Gastric anastomotic leak
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Investigations
ALT increased
|
0.61%
1/163 • 120 days after activation
|
2.5%
4/163 • 120 days after activation
|
|
Investigations
Creatinine increased
|
1.8%
3/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Investigations
Weight gain
|
1.8%
3/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Investigations
AST increased
|
0.61%
1/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Investigations
Blood bilirubin increased
|
0.61%
1/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Investigations
Other investigation abnormal
|
0.61%
1/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Investigations
Urine output decreased
|
0.61%
1/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Investigations
Weight loss
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Investigations
Alk phos increased
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
11/163 • 120 days after activation
|
3.1%
5/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Other metabolism disorder
|
2.5%
4/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.5%
4/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.8%
3/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Acidosis
|
0.61%
1/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.2%
2/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.61%
1/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.2%
2/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
7/163 • 120 days after activation
|
4.9%
8/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
7/163 • 120 days after activation
|
3.1%
5/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
5/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.2%
2/163 • 120 days after activation
|
2.5%
4/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.61%
1/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal disorder
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
2/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Joint ROM decreased
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other neoplasm
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Nervous system disorders
Headache
|
9.8%
16/163 • 120 days after activation
|
6.1%
10/163 • 120 days after activation
|
|
Nervous system disorders
Dizziness
|
5.5%
9/163 • 120 days after activation
|
3.1%
5/163 • 120 days after activation
|
|
Nervous system disorders
Other nervous sys disorder
|
1.8%
3/163 • 120 days after activation
|
3.1%
5/163 • 120 days after activation
|
|
Nervous system disorders
Paresthesia
|
2.5%
4/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Nervous system disorders
Syncope
|
1.8%
3/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.8%
3/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.61%
1/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Nervous system disorders
Seizure
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Nervous system disorders
Ataxia
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Nervous system disorders
Dysgeusia
|
1.2%
2/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Nervous system disorders
Tremor
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Nervous system disorders
Akathisia
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Nervous system disorders
Transient ischemic attacks
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Nervous system disorders
Stroke
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Nervous system disorders
Somnolence
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Nervous system disorders
Dysesthesia
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Nervous system disorders
Lethargy
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Psychiatric disorders
Insomnia
|
6.7%
11/163 • 120 days after activation
|
4.3%
7/163 • 120 days after activation
|
|
Psychiatric disorders
Other psychiatric disorder
|
2.5%
4/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Psychiatric disorders
Anxiety
|
1.2%
2/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Psychiatric disorders
Depression
|
1.8%
3/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Psychiatric disorders
Delirium
|
0.61%
1/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Psychiatric disorders
Confusion
|
0.00%
0/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Psychiatric disorders
Restlessness
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Renal and urinary disorders
Acute kidney injury
|
4.3%
7/163 • 120 days after activation
|
3.7%
6/163 • 120 days after activation
|
|
Renal and urinary disorders
Other renal disorder
|
3.1%
5/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Renal and urinary disorders
Urinary frequency
|
1.2%
2/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Renal and urinary disorders
Hematuria
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Renal and urinary disorders
Urinary retention
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Reproductive system and breast disorders
Other reproductive sys disorder
|
1.8%
3/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Reproductive system and breast disorders
Testicular pain
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.1%
10/163 • 120 days after activation
|
6.1%
10/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory disorder
|
4.9%
8/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.1%
10/163 • 120 days after activation
|
4.3%
7/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.1%
5/163 • 120 days after activation
|
4.3%
7/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
3/163 • 120 days after activation
|
4.3%
7/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.8%
3/163 • 120 days after activation
|
4.3%
7/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.8%
3/163 • 120 days after activation
|
2.5%
4/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.61%
1/163 • 120 days after activation
|
3.1%
5/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
1.8%
3/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.2%
2/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.61%
1/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.2%
2/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.1%
5/163 • 120 days after activation
|
7.4%
12/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Other skin disorder
|
3.1%
5/163 • 120 days after activation
|
4.3%
7/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
4/163 • 120 days after activation
|
2.5%
4/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.5%
4/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.5%
4/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
2/163 • 120 days after activation
|
1.8%
3/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.61%
1/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/163 • 120 days after activation
|
1.2%
2/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/163 • 120 days after activation
|
0.61%
1/163 • 120 days after activation
|
|
Vascular disorders
Hypotension
|
8.0%
13/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Vascular disorders
Hypertension
|
3.7%
6/163 • 120 days after activation
|
4.3%
7/163 • 120 days after activation
|
|
Vascular disorders
Thromboembolic event
|
1.8%
3/163 • 120 days after activation
|
2.5%
4/163 • 120 days after activation
|
|
Vascular disorders
Flushing
|
0.61%
1/163 • 120 days after activation
|
0.00%
0/163 • 120 days after activation
|
Other adverse events
| Measure |
Tranexamic Acid (TXA)
n=163 participants at risk
IV or PO administered after meeting inclusion/exclusion criteria
Tranexamic Acid: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered
|
Placebo
n=163 participants at risk
IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria
Placebo: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
49.7%
81/163 • 120 days after activation
|
46.0%
75/163 • 120 days after activation
|
|
Cardiac disorders
Sinus tachycardia
|
42.9%
70/163 • 120 days after activation
|
39.9%
65/163 • 120 days after activation
|
|
Cardiac disorders
Sinus bradycardia
|
8.6%
14/163 • 120 days after activation
|
4.9%
8/163 • 120 days after activation
|
|
Cardiac disorders
Other cardiac
|
6.1%
10/163 • 120 days after activation
|
3.7%
6/163 • 120 days after activation
|
|
Ear and labyrinth disorders
Other
|
5.5%
9/163 • 120 days after activation
|
2.5%
4/163 • 120 days after activation
|
|
Eye disorders
Blurred vision
|
11.0%
18/163 • 120 days after activation
|
7.4%
12/163 • 120 days after activation
|
|
Eye disorders
Other eye disorder
|
5.5%
9/163 • 120 days after activation
|
11.0%
18/163 • 120 days after activation
|
|
General disorders
Fatigue
|
61.3%
100/163 • 120 days after activation
|
62.6%
102/163 • 120 days after activation
|
|
General disorders
Edema limbs
|
39.9%
65/163 • 120 days after activation
|
39.3%
64/163 • 120 days after activation
|
|
General disorders
Chills
|
17.2%
28/163 • 120 days after activation
|
16.6%
27/163 • 120 days after activation
|
|
General disorders
Infusion related reaction
|
16.0%
26/163 • 120 days after activation
|
17.8%
29/163 • 120 days after activation
|
|
General disorders
Fever
|
15.3%
25/163 • 120 days after activation
|
17.2%
28/163 • 120 days after activation
|
|
General disorders
Other general disorder
|
16.0%
26/163 • 120 days after activation
|
14.7%
24/163 • 120 days after activation
|
|
General disorders
Pain
|
14.1%
23/163 • 120 days after activation
|
9.2%
15/163 • 120 days after activation
|
|
General disorders
Injection site reaction
|
9.2%
15/163 • 120 days after activation
|
10.4%
17/163 • 120 days after activation
|
|
General disorders
Non-cardiac chest pain
|
9.8%
16/163 • 120 days after activation
|
5.5%
9/163 • 120 days after activation
|
|
General disorders
Localized edema
|
6.7%
11/163 • 120 days after activation
|
7.4%
12/163 • 120 days after activation
|
|
General disorders
Edema face
|
6.7%
11/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Gastrointestinal disorders
Diarrhea
|
69.9%
114/163 • 120 days after activation
|
68.7%
112/163 • 120 days after activation
|
|
Gastrointestinal disorders
Nausea
|
58.3%
95/163 • 120 days after activation
|
55.8%
91/163 • 120 days after activation
|
|
Gastrointestinal disorders
Abdominal pain
|
41.7%
68/163 • 120 days after activation
|
33.7%
55/163 • 120 days after activation
|
|
Gastrointestinal disorders
Mucositis oral
|
35.6%
58/163 • 120 days after activation
|
38.7%
63/163 • 120 days after activation
|
|
Gastrointestinal disorders
Vomiting
|
39.9%
65/163 • 120 days after activation
|
34.4%
56/163 • 120 days after activation
|
|
Gastrointestinal disorders
Constipation
|
26.4%
43/163 • 120 days after activation
|
31.9%
52/163 • 120 days after activation
|
|
Gastrointestinal disorders
Other gastrointestinal
|
22.1%
36/163 • 120 days after activation
|
25.8%
42/163 • 120 days after activation
|
|
Gastrointestinal disorders
Dry mouth
|
12.3%
20/163 • 120 days after activation
|
15.3%
25/163 • 120 days after activation
|
|
Gastrointestinal disorders
Dyspepsia
|
16.0%
26/163 • 120 days after activation
|
10.4%
17/163 • 120 days after activation
|
|
Gastrointestinal disorders
Oral pain
|
9.2%
15/163 • 120 days after activation
|
9.2%
15/163 • 120 days after activation
|
|
Gastrointestinal disorders
Gastroesoph reflux disease
|
8.0%
13/163 • 120 days after activation
|
8.6%
14/163 • 120 days after activation
|
|
Gastrointestinal disorders
Bloating
|
8.6%
14/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Gastrointestinal disorders
Rectal pain
|
7.4%
12/163 • 120 days after activation
|
7.4%
12/163 • 120 days after activation
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.8%
16/163 • 120 days after activation
|
4.3%
7/163 • 120 days after activation
|
|
Gastrointestinal disorders
Fecal incontinence
|
3.7%
6/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Gastrointestinal disorders
Abdominal distension
|
5.5%
9/163 • 120 days after activation
|
4.3%
7/163 • 120 days after activation
|
|
Hepatobiliary disorders
Other hepatobiliary
|
6.7%
11/163 • 120 days after activation
|
4.9%
8/163 • 120 days after activation
|
|
Immune system disorders
Other immune disorder
|
12.9%
21/163 • 120 days after activation
|
8.6%
14/163 • 120 days after activation
|
|
Infections and infestations
Other infection
|
31.9%
52/163 • 120 days after activation
|
31.9%
52/163 • 120 days after activation
|
|
Infections and infestations
Skin infection
|
8.6%
14/163 • 120 days after activation
|
13.5%
22/163 • 120 days after activation
|
|
Infections and infestations
Sinusitis
|
8.0%
13/163 • 120 days after activation
|
9.2%
15/163 • 120 days after activation
|
|
Infections and infestations
Lung infection
|
8.6%
14/163 • 120 days after activation
|
3.7%
6/163 • 120 days after activation
|
|
Injury, poisoning and procedural complications
Other injury
|
5.5%
9/163 • 120 days after activation
|
8.0%
13/163 • 120 days after activation
|
|
Investigations
ALT increased
|
16.6%
27/163 • 120 days after activation
|
11.7%
19/163 • 120 days after activation
|
|
Investigations
AST increased
|
13.5%
22/163 • 120 days after activation
|
9.8%
16/163 • 120 days after activation
|
|
Investigations
Weight gain
|
6.1%
10/163 • 120 days after activation
|
7.4%
12/163 • 120 days after activation
|
|
Investigations
Blood bilirubin increased
|
9.2%
15/163 • 120 days after activation
|
4.3%
7/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Anorexia
|
42.3%
69/163 • 120 days after activation
|
39.9%
65/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.4%
30/163 • 120 days after activation
|
14.1%
23/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Other metabolism disorder
|
15.3%
25/163 • 120 days after activation
|
13.5%
22/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.7%
24/163 • 120 days after activation
|
11.7%
19/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.2%
15/163 • 120 days after activation
|
11.0%
18/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
13/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.5%
9/163 • 120 days after activation
|
3.7%
6/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.8%
42/163 • 120 days after activation
|
27.0%
44/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
19.6%
32/163 • 120 days after activation
|
21.5%
35/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.1%
36/163 • 120 days after activation
|
17.2%
28/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.6%
32/163 • 120 days after activation
|
18.4%
30/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.4%
12/163 • 120 days after activation
|
4.9%
8/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.7%
6/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.9%
8/163 • 120 days after activation
|
5.5%
9/163 • 120 days after activation
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal disorder
|
2.5%
4/163 • 120 days after activation
|
6.1%
10/163 • 120 days after activation
|
|
Nervous system disorders
Headache
|
40.5%
66/163 • 120 days after activation
|
41.1%
67/163 • 120 days after activation
|
|
Nervous system disorders
Dizziness
|
23.3%
38/163 • 120 days after activation
|
23.3%
38/163 • 120 days after activation
|
|
Nervous system disorders
Dysgeusia
|
20.9%
34/163 • 120 days after activation
|
18.4%
30/163 • 120 days after activation
|
|
Nervous system disorders
Tremor
|
9.8%
16/163 • 120 days after activation
|
11.7%
19/163 • 120 days after activation
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.6%
14/163 • 120 days after activation
|
8.6%
14/163 • 120 days after activation
|
|
Nervous system disorders
Paresthesia
|
5.5%
9/163 • 120 days after activation
|
9.2%
15/163 • 120 days after activation
|
|
Psychiatric disorders
Insomnia
|
22.7%
37/163 • 120 days after activation
|
30.1%
49/163 • 120 days after activation
|
|
Psychiatric disorders
Anxiety
|
18.4%
30/163 • 120 days after activation
|
20.2%
33/163 • 120 days after activation
|
|
Psychiatric disorders
Confusion
|
8.0%
13/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Psychiatric disorders
Depression
|
6.1%
10/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Psychiatric disorders
Other psychiatric disorder
|
5.5%
9/163 • 120 days after activation
|
4.9%
8/163 • 120 days after activation
|
|
Renal and urinary disorders
Other renal disorder
|
16.6%
27/163 • 120 days after activation
|
16.0%
26/163 • 120 days after activation
|
|
Renal and urinary disorders
Urinary frequency
|
11.7%
19/163 • 120 days after activation
|
8.0%
13/163 • 120 days after activation
|
|
Renal and urinary disorders
Acute kidney injury
|
4.9%
8/163 • 120 days after activation
|
10.4%
17/163 • 120 days after activation
|
|
Renal and urinary disorders
Urinary urgency
|
6.1%
10/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Renal and urinary disorders
Urinary incontinence
|
5.5%
9/163 • 120 days after activation
|
4.9%
8/163 • 120 days after activation
|
|
Renal and urinary disorders
Urinary retention
|
5.5%
9/163 • 120 days after activation
|
3.1%
5/163 • 120 days after activation
|
|
Reproductive system and breast disorders
Other reproductive sys disorder
|
5.5%
9/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.3%
38/163 • 120 days after activation
|
32.5%
53/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.5%
40/163 • 120 days after activation
|
25.2%
41/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory disorder
|
20.2%
33/163 • 120 days after activation
|
20.2%
33/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
19.6%
32/163 • 120 days after activation
|
20.2%
33/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
14.7%
24/163 • 120 days after activation
|
19.0%
31/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.0%
26/163 • 120 days after activation
|
12.9%
21/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.3%
20/163 • 120 days after activation
|
12.3%
20/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.1%
23/163 • 120 days after activation
|
10.4%
17/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.4%
17/163 • 120 days after activation
|
9.8%
16/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
9.2%
15/163 • 120 days after activation
|
9.8%
16/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.5%
9/163 • 120 days after activation
|
11.0%
18/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.4%
12/163 • 120 days after activation
|
6.7%
11/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.6%
14/163 • 120 days after activation
|
5.5%
9/163 • 120 days after activation
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.5%
9/163 • 120 days after activation
|
4.9%
8/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
43.6%
71/163 • 120 days after activation
|
38.0%
62/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Other skin disorder
|
24.5%
40/163 • 120 days after activation
|
32.5%
53/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.2%
41/163 • 120 days after activation
|
29.4%
48/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.3%
20/163 • 120 days after activation
|
19.0%
31/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.0%
13/163 • 120 days after activation
|
9.8%
16/163 • 120 days after activation
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
10.4%
17/163 • 120 days after activation
|
6.1%
10/163 • 120 days after activation
|
|
Vascular disorders
Hypotension
|
32.5%
53/163 • 120 days after activation
|
34.4%
56/163 • 120 days after activation
|
|
Vascular disorders
Hypertension
|
30.7%
50/163 • 120 days after activation
|
34.4%
56/163 • 120 days after activation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place