Trial Outcomes & Findings for Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia (NCT NCT00061945)
NCT ID: NCT00061945
Last Updated: 2022-05-03
Results Overview
The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
302 participants
Primary outcome timeframe
6 weeks
Results posted on
2022-05-03
Participant Flow
From June 2003 to May 2007, a total of 302 participants were recruited.
Two (2) participants cancelled prior to receiving any treatment and were removed from all analyses.
Participant milestones
| Measure |
Phase I - Alemtuzumab and Combination Chemotherapy
COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d1,8,15 \& 22, dexamethasone (DEX) PO 2x daily (BID) d1-7 \& 15-21, asparaginase (APG) subcutaneously (SC) d5,8,11,15,18 \& 22, and filgrastim (FIL) SC d4-11. Ph+ pts imatinib (IMT) PO d15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG \& FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d1,15 \& 29, MTX IV \& IT d1,15 \& 19, MTX PO q6 hr d1-2,15-16 \& 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 \& 30, LCV PO q6 hr d3-4 \& CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 10,20 or 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d1,8,15 \& 22 and CRT PO BID 3d wkly. Ph+ pts IMT PO d1-28 q24 mo
|
Phase II - Alemtuzumab and Combination Chemotherapy
COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d 1,8,15 \& 22, dexamethasone (DEX) PO 2x daily (BID) d 1-7 \& 15-21, asparaginase (APG) subcutaneously (SC) d 5,8,11,15,18 \& 22, and filgrastim (FIL) SC d 4-11. Ph+ pts imatinib (IMT) PO d 15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d 1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG \& FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d 1,15 \& 29, MTX IV \& IT d 1,15 \& 19, MTX PO q6 hr d 1-2,15-16 \& 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 \& 30, LCV PO q6 hr d 3-4 \& CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d 1,8,15 \& 22 and CRT PO BID 3x wkly. Ph+ pts IMT PO d1-28 q24 mo
|
|---|---|---|
|
Registration Through Course 3
STARTED
|
119
|
181
|
|
Registration Through Course 3
COMPLETED
|
25
|
66
|
|
Registration Through Course 3
NOT COMPLETED
|
94
|
115
|
|
Course IV: Alemtuzumab
STARTED
|
25
|
66
|
|
Course IV: Alemtuzumab
COMPLETED
|
18
|
50
|
|
Course IV: Alemtuzumab
NOT COMPLETED
|
7
|
16
|
Reasons for withdrawal
| Measure |
Phase I - Alemtuzumab and Combination Chemotherapy
COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d1,8,15 \& 22, dexamethasone (DEX) PO 2x daily (BID) d1-7 \& 15-21, asparaginase (APG) subcutaneously (SC) d5,8,11,15,18 \& 22, and filgrastim (FIL) SC d4-11. Ph+ pts imatinib (IMT) PO d15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG \& FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d1,15 \& 29, MTX IV \& IT d1,15 \& 19, MTX PO q6 hr d1-2,15-16 \& 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 \& 30, LCV PO q6 hr d3-4 \& CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 10,20 or 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d1,8,15 \& 22 and CRT PO BID 3d wkly. Ph+ pts IMT PO d1-28 q24 mo
|
Phase II - Alemtuzumab and Combination Chemotherapy
COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d 1,8,15 \& 22, dexamethasone (DEX) PO 2x daily (BID) d 1-7 \& 15-21, asparaginase (APG) subcutaneously (SC) d 5,8,11,15,18 \& 22, and filgrastim (FIL) SC d 4-11. Ph+ pts imatinib (IMT) PO d 15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d 1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG \& FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d 1,15 \& 29, MTX IV \& IT d 1,15 \& 19, MTX PO q6 hr d 1-2,15-16 \& 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 \& 30, LCV PO q6 hr d 3-4 \& CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d 1,8,15 \& 22 and CRT PO BID 3x wkly. Ph+ pts IMT PO d1-28 q24 mo
|
|---|---|---|
|
Registration Through Course 3
Not Alemtuzumab Eligible
|
18
|
25
|
|
Registration Through Course 3
Early discontinuation during course I-IV
|
76
|
90
|
|
Course IV: Alemtuzumab
Declined Alemtuzumab
|
1
|
1
|
|
Course IV: Alemtuzumab
Early exits
|
6
|
15
|
Baseline Characteristics
Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Phase I - Alemtuzumab and Combination Chemotherapy
n=119 Participants
See detailed description or participant flow.
|
Phase II - Alemtuzumab and Combination Chemotherapy
n=181 Participants
See detailed description or participant flow.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.3 years
n=5 Participants
|
46.5 years
n=7 Participants
|
46.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=5 Participants
|
181 participants
n=7 Participants
|
300 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis.
The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.
Outcome measures
| Measure |
Phase I - Alemtuzumab and Combination Chemotherapy
n=24 Participants
See detailed description or participant flow.
|
Phase II - Alemtuzumab and Combination Chemotherapy
See detailed description or participant flow.
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)
|
30 mg
|
—
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis.
The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV.
Outcome measures
| Measure |
Phase I - Alemtuzumab and Combination Chemotherapy
n=65 Participants
See detailed description or participant flow.
|
Phase II - Alemtuzumab and Combination Chemotherapy
See detailed description or participant flow.
|
|---|---|---|
|
Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)
|
30 participants
|
—
|
SECONDARY outcome
Timeframe: 9 years 4 monthsPopulation: Patients who reported a Complete Response (CR) during treatment and were analyzed for the presence of circulating leukemia cells.
Minimal Residual Disease measures the presence of of circulating leukemia cells in the body. Patients that report a Complete Response (CR) during treatment are further tested to determine the presence of small amounts of circulating leukemia cells. Here we report the number of patients who were MRD negative.
Outcome measures
| Measure |
Phase I - Alemtuzumab and Combination Chemotherapy
n=51 Participants
See detailed description or participant flow.
|
Phase II - Alemtuzumab and Combination Chemotherapy
See detailed description or participant flow.
|
|---|---|---|
|
Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II)
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: 9 years 4 monthsPopulation: All patients who received protocol treatment and had a complete response (CR) during treatment were included in this analysis. Phase I patients, who achieved complete response, were included with the phase II patients, who achieved complete response, for this analysis.
Disease Free Survival (DFS) is defined as the time from a Complete Response (CR) until death or relapse. The date of last clinical assesment will be used as the censor date for patients with no death or relapse. The DFS will be estimated using the Kaplan-Meier method with confidence intervals presented.
Outcome measures
| Measure |
Phase I - Alemtuzumab and Combination Chemotherapy
n=92 Participants
See detailed description or participant flow.
|
Phase II - Alemtuzumab and Combination Chemotherapy
n=145 Participants
See detailed description or participant flow.
|
|---|---|---|
|
Disease-free Survival, for Only Complete Response Patients
|
58.6 months
Interval 24.8 to 103.8
|
19.8 months
Interval 14.3 to 28.4
|
SECONDARY outcome
Timeframe: 9 years 4 monthsPopulation: All patients who registered, received protocol treatment, and were eligible were evaluated for this endpoint. Phase I patients were included with the phase II patients for this analysis.
Overall Survival is defines as the time from registration to death due to any cause. It is estimated using the Kaplan-Meier method with confidence intervals presented.
Outcome measures
| Measure |
Phase I - Alemtuzumab and Combination Chemotherapy
n=116 Participants
See detailed description or participant flow.
|
Phase II - Alemtuzumab and Combination Chemotherapy
n=181 Participants
See detailed description or participant flow.
|
|---|---|---|
|
Overall Survival
|
33.6 months
Interval 19.8 to 72.1
|
23.1 months
Interval 18.4 to 32.0
|
POST_HOC outcome
Timeframe: 9 yearsPopulation: Three participants were deemed ineligible and excluded from this analysis.
A complete remission (CR) requires the following: an absolute neutrophil count (segs and bands) \> 1500/μl, no circulating blasts, platelets \> 100,000/μl; bone marrow cellularity \> 20% with trilineage hematopoiesis, and \< 5% marrow blast cells, none of which appear neoplastic. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement).
Outcome measures
| Measure |
Phase I - Alemtuzumab and Combination Chemotherapy
n=116 Participants
See detailed description or participant flow.
|
Phase II - Alemtuzumab and Combination Chemotherapy
n=181 Participants
See detailed description or participant flow.
|
|---|---|---|
|
Number of Participants Achieving Complete Remission
|
92 participants
|
145 participants
|
Adverse Events
Phase I - Alemtuzumab and Combination Chemotherapy
Serious events: 60 serious events
Other events: 99 other events
Deaths: 0 deaths
Phase II - Alemtuzumab and Combination Chemotherapy
Serious events: 98 serious events
Other events: 152 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I - Alemtuzumab and Combination Chemotherapy
n=119 participants at risk
See detailed description or participant flow.
|
Phase II - Alemtuzumab and Combination Chemotherapy
n=181 participants at risk
See detailed description or participant flow.
|
|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
2.5%
3/119 • Number of events 3
|
2.8%
5/181 • Number of events 5
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
26.9%
32/119 • Number of events 35
|
24.3%
44/181 • Number of events 52
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
49.6%
59/119 • Number of events 86
|
50.8%
92/181 • Number of events 146
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Cardiac disorders
Asystole
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
3/119 • Number of events 3
|
2.8%
5/181 • Number of events 6
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Cardiac disorders
Cardiac pain
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 4
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Conduction disorder
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Cardiac disorders
Left ventricular failure
|
4.2%
5/119 • Number of events 6
|
3.3%
6/181 • Number of events 8
|
|
Cardiac disorders
Myocardial ischemia
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/119
|
2.2%
4/181 • Number of events 5
|
|
Cardiac disorders
Sinus bradycardia
|
1.7%
2/119 • Number of events 2
|
1.1%
2/181 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
4.2%
5/119 • Number of events 6
|
5.5%
10/181 • Number of events 12
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Cardiac disorders
Ventricular bigeminy
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Endocrine disorders
Adrenal insufficiency
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Eye disorders
Diplopia
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Eye disorders
Dry eye syndrome
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Eye disorders
Eye disorder
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Eye disorders
Photophobia
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Eye disorders
Proptosis
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Eye disorders
Vision blurred
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
2.5%
3/119 • Number of events 3
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
10.1%
12/119 • Number of events 12
|
14.4%
26/181 • Number of events 29
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
3.4%
4/119 • Number of events 4
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
0.84%
1/119 • Number of events 1
|
5.0%
9/181 • Number of events 11
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Colonic perforation
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
11.8%
14/119 • Number of events 15
|
11.6%
21/181 • Number of events 26
|
|
Gastrointestinal disorders
Diarrhea
|
16.8%
20/119 • Number of events 23
|
26.5%
48/181 • Number of events 59
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/119
|
2.2%
4/181 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
6/119 • Number of events 6
|
6.1%
11/181 • Number of events 11
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
2/119 • Number of events 2
|
5.5%
10/181 • Number of events 10
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
7.6%
9/119 • Number of events 9
|
9.9%
18/181 • Number of events 19
|
|
Gastrointestinal disorders
Endoscopy large bowel abnormal
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal pain
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/119
|
1.7%
3/181 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
2/119 • Number of events 2
|
2.2%
4/181 • Number of events 4
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.84%
1/119 • Number of events 1
|
2.8%
5/181 • Number of events 5
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/119
|
0.55%
1/181 • Number of events 2
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 4
|
|
Gastrointestinal disorders
Intestinal necrosis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 4
|
|
Gastrointestinal disorders
Mucositis oral
|
10.9%
13/119 • Number of events 13
|
7.7%
14/181 • Number of events 15
|
|
Gastrointestinal disorders
Nausea
|
23.5%
28/119 • Number of events 35
|
30.4%
55/181 • Number of events 78
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Oral pain
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 4
|
|
Gastrointestinal disorders
Pancreatitis
|
1.7%
2/119 • Number of events 2
|
3.3%
6/181 • Number of events 7
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Gastrointestinal disorders
Rectal pain
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/119
|
0.55%
1/181 • Number of events 2
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Gastrointestinal disorders
Typhlitis
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Gastrointestinal disorders
Vomiting
|
15.1%
18/119 • Number of events 21
|
22.1%
40/181 • Number of events 53
|
|
General disorders
Chest pain
|
2.5%
3/119 • Number of events 4
|
3.9%
7/181 • Number of events 8
|
|
General disorders
Chills
|
7.6%
9/119 • Number of events 9
|
8.8%
16/181 • Number of events 20
|
|
General disorders
Edema limbs
|
12.6%
15/119 • Number of events 18
|
14.4%
26/181 • Number of events 35
|
|
General disorders
Facial pain
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
General disorders
Fatigue
|
27.7%
33/119 • Number of events 42
|
29.8%
54/181 • Number of events 82
|
|
General disorders
Fever
|
5.0%
6/119 • Number of events 7
|
13.8%
25/181 • Number of events 33
|
|
General disorders
Gait abnormal
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
General disorders
General symptom
|
2.5%
3/119 • Number of events 3
|
0.00%
0/181
|
|
General disorders
Ill-defined disorder
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
General disorders
Injection site reaction
|
3.4%
4/119 • Number of events 4
|
1.1%
2/181 • Number of events 2
|
|
General disorders
Irritability
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
General disorders
Localized edema
|
0.00%
0/119
|
2.2%
4/181 • Number of events 5
|
|
General disorders
Multi-organ failure
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
General disorders
Pain
|
4.2%
5/119 • Number of events 5
|
3.3%
6/181 • Number of events 6
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
2.5%
3/119 • Number of events 3
|
3.9%
7/181 • Number of events 7
|
|
Immune system disorders
Hypersensitivity
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Infections and infestations
Abdominal infection
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/119
|
2.2%
4/181 • Number of events 4
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
0.84%
1/119 • Number of events 1
|
3.3%
6/181 • Number of events 6
|
|
Infections and infestations
Bronchitis
|
0.00%
0/119
|
1.1%
2/181 • Number of events 3
|
|
Infections and infestations
Catheter related infection
|
5.0%
6/119 • Number of events 6
|
5.0%
9/181 • Number of events 11
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Device related infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Encephalomyelitis infection
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Infections and infestations
Endocarditis infective
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Infections and infestations
Eye infection
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 2
|
|
Infections and infestations
Infection
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 4
|
|
Infections and infestations
Infectious colitis
|
2.5%
3/119 • Number of events 3
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Infectious meningitis
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Joint infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Lip infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Opportunistic infection
|
2.5%
3/119 • Number of events 3
|
2.2%
4/181 • Number of events 4
|
|
Infections and infestations
Peripheral nerve infection
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Pleural infection
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Infections and infestations
Pneumonia
|
7.6%
9/119 • Number of events 11
|
8.8%
16/181 • Number of events 20
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Sepsis
|
20.2%
24/119 • Number of events 27
|
28.7%
52/181 • Number of events 68
|
|
Infections and infestations
Sinusitis
|
1.7%
2/119 • Number of events 2
|
3.3%
6/181 • Number of events 6
|
|
Infections and infestations
Skin infection
|
3.4%
4/119 • Number of events 4
|
5.0%
9/181 • Number of events 9
|
|
Infections and infestations
Small intestine infection
|
0.84%
1/119 • Number of events 2
|
1.1%
2/181 • Number of events 2
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Infections and infestations
Spinal cord infection
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Infections and infestations
Upper respiratory infection
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Infections and infestations
Ureteritis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Urethral infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
5.0%
6/119 • Number of events 6
|
4.4%
8/181 • Number of events 9
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Viral hepatitis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Vulval infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Injury, poisoning and procedural complications
Prolonged intubation after pulmonary resection (>24 hrs after surgery)
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Injury, poisoning and procedural complications
Seroma
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/119
|
2.2%
4/181 • Number of events 4
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Investigations
Activated partial thromboplastin time prolonged
|
9.2%
11/119 • Number of events 12
|
13.3%
24/181 • Number of events 29
|
|
Investigations
Alanine aminotransferase increased
|
26.1%
31/119 • Number of events 39
|
33.7%
61/181 • Number of events 83
|
|
Investigations
Alkaline phosphatase increased
|
13.4%
16/119 • Number of events 21
|
24.3%
44/181 • Number of events 48
|
|
Investigations
Amylase increased
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
27.7%
33/119 • Number of events 39
|
33.7%
61/181 • Number of events 82
|
|
Investigations
Blood bilirubin increased
|
40.3%
48/119 • Number of events 54
|
32.6%
59/181 • Number of events 79
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Investigations
Cardiac troponin T increased
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 6
|
|
Investigations
Coagulopathy
|
1.7%
2/119 • Number of events 2
|
3.9%
7/181 • Number of events 7
|
|
Investigations
Creatinine increased
|
21.0%
25/119 • Number of events 27
|
20.4%
37/181 • Number of events 50
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Investigations
Fibrinogen decreased
|
21.0%
25/119 • Number of events 25
|
22.1%
40/181 • Number of events 42
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.2%
5/119 • Number of events 7
|
1.1%
2/181 • Number of events 2
|
|
Investigations
INR increased
|
2.5%
3/119 • Number of events 3
|
8.3%
15/181 • Number of events 22
|
|
Investigations
Laboratory test abnormal
|
2.5%
3/119 • Number of events 3
|
2.2%
4/181 • Number of events 10
|
|
Investigations
Leukocyte count decreased
|
7.6%
9/119 • Number of events 11
|
12.2%
22/181 • Number of events 37
|
|
Investigations
Lipase increased
|
0.00%
0/119
|
5.5%
10/181 • Number of events 11
|
|
Investigations
Lymphocyte count decreased
|
4.2%
5/119 • Number of events 7
|
7.2%
13/181 • Number of events 16
|
|
Investigations
Neutrophil count decreased
|
49.6%
59/119 • Number of events 81
|
49.7%
90/181 • Number of events 137
|
|
Investigations
Platelet count decreased
|
49.6%
59/119 • Number of events 80
|
49.2%
89/181 • Number of events 141
|
|
Investigations
Weight gain
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Investigations
Weight loss
|
2.5%
3/119 • Number of events 4
|
5.0%
9/181 • Number of events 9
|
|
Metabolism and nutrition disorders
Alkalosis
|
1.7%
2/119 • Number of events 2
|
0.00%
0/181
|
|
Metabolism and nutrition disorders
Anorexia
|
13.4%
16/119 • Number of events 18
|
17.7%
32/181 • Number of events 36
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
1.7%
2/119 • Number of events 3
|
1.7%
3/181 • Number of events 4
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
47.1%
56/119 • Number of events 75
|
43.6%
79/181 • Number of events 122
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
1.7%
2/119 • Number of events 2
|
5.0%
9/181 • Number of events 12
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
5/119 • Number of events 5
|
3.9%
7/181 • Number of events 7
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Metabolism and nutrition disorders
Renal tubular disorder
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
30.3%
36/119 • Number of events 41
|
22.1%
40/181 • Number of events 63
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
31.1%
37/119 • Number of events 45
|
28.7%
52/181 • Number of events 75
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
1.7%
2/119 • Number of events 2
|
2.8%
5/181 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
4.2%
5/119 • Number of events 5
|
3.9%
7/181 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
10.1%
12/119 • Number of events 13
|
15.5%
28/181 • Number of events 33
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
2.5%
3/119 • Number of events 3
|
10.5%
19/181 • Number of events 19
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
12.6%
15/119 • Number of events 15
|
10.5%
19/181 • Number of events 22
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
20.2%
24/119 • Number of events 27
|
23.8%
43/181 • Number of events 64
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
5.0%
6/119 • Number of events 6
|
5.0%
9/181 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
19.3%
23/119 • Number of events 27
|
19.3%
35/181 • Number of events 44
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
4.2%
5/119 • Number of events 6
|
6.6%
12/181 • Number of events 15
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/119
|
2.2%
4/181 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
2/119 • Number of events 2
|
3.9%
7/181 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
2/119 • Number of events 2
|
10.5%
19/181 • Number of events 21
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
2/119 • Number of events 2
|
1.1%
2/181 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.7%
2/119 • Number of events 2
|
1.7%
3/181 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.2%
5/119 • Number of events 5
|
5.0%
9/181 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/119
|
3.3%
6/181 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
4/119 • Number of events 5
|
3.3%
6/181 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
2/119 • Number of events 2
|
0.55%
1/181 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
7/119 • Number of events 7
|
5.0%
9/181 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
4.2%
5/119 • Number of events 6
|
1.1%
2/181 • Number of events 2
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
1.7%
2/119 • Number of events 2
|
2.8%
5/181 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
8.4%
10/119 • Number of events 11
|
6.6%
12/181 • Number of events 13
|
|
Nervous system disorders
Dysgeusia
|
0.84%
1/119 • Number of events 1
|
2.8%
5/181 • Number of events 5
|
|
Nervous system disorders
Encephalopathy
|
1.7%
2/119 • Number of events 2
|
0.00%
0/181
|
|
Nervous system disorders
Headache
|
10.9%
13/119 • Number of events 13
|
14.9%
27/181 • Number of events 33
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.4%
4/119 • Number of events 4
|
1.1%
2/181 • Number of events 2
|
|
Nervous system disorders
Ischemia cerebrovascular
|
2.5%
3/119 • Number of events 3
|
1.7%
3/181 • Number of events 3
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Mini mental status examination abnormal
|
1.7%
2/119 • Number of events 2
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 4
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.2%
5/119 • Number of events 6
|
4.4%
8/181 • Number of events 10
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.6%
15/119 • Number of events 16
|
14.4%
26/181 • Number of events 36
|
|
Nervous system disorders
Seizure
|
0.84%
1/119 • Number of events 1
|
2.8%
5/181 • Number of events 5
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/119
|
1.7%
3/181 • Number of events 3
|
|
Nervous system disorders
Speech disorder
|
3.4%
4/119 • Number of events 4
|
0.00%
0/181
|
|
Nervous system disorders
Syncope
|
2.5%
3/119 • Number of events 3
|
2.8%
5/181 • Number of events 5
|
|
Nervous system disorders
Tremor
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Psychiatric disorders
Agitation
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
3.4%
4/119 • Number of events 5
|
5.5%
10/181 • Number of events 10
|
|
Psychiatric disorders
Confusion
|
5.0%
6/119 • Number of events 6
|
5.5%
10/181 • Number of events 11
|
|
Psychiatric disorders
Depression
|
2.5%
3/119 • Number of events 3
|
5.0%
9/181 • Number of events 10
|
|
Psychiatric disorders
Euphoria
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
5.0%
6/119 • Number of events 7
|
5.5%
10/181 • Number of events 10
|
|
Psychiatric disorders
Psychosis
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Renal and urinary disorders
Bladder hemorrhage
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/119
|
1.7%
3/181 • Number of events 4
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/119
|
1.7%
3/181 • Number of events 7
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
1.7%
2/119 • Number of events 2
|
1.7%
3/181 • Number of events 4
|
|
Renal and urinary disorders
Proteinuria
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Renal and urinary disorders
Renal failure
|
5.0%
6/119 • Number of events 6
|
3.9%
7/181 • Number of events 12
|
|
Renal and urinary disorders
Ureteric hemorrhage
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
1.7%
2/119 • Number of events 2
|
1.7%
3/181 • Number of events 3
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/119
|
1.7%
3/181 • Number of events 3
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.84%
1/119 • Number of events 1
|
3.9%
7/181 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.84%
1/119 • Number of events 2
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.7%
2/119 • Number of events 3
|
1.7%
3/181 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.4%
10/119 • Number of events 11
|
11.6%
21/181 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
17/119 • Number of events 19
|
16.0%
29/181 • Number of events 40
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
7/119 • Number of events 7
|
1.7%
3/181 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/119
|
2.8%
5/181 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
7/119 • Number of events 8
|
8.8%
16/181 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.4%
4/119 • Number of events 4
|
2.2%
4/181 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
7/119 • Number of events 7
|
5.5%
10/181 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
3/119 • Number of events 4
|
5.5%
10/181 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.7%
2/119 • Number of events 2
|
3.3%
6/181 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
5/119 • Number of events 5
|
7.7%
14/181 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/119
|
3.9%
7/181 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/119
|
1.7%
3/181 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.2%
5/119 • Number of events 5
|
3.9%
7/181 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
3/119 • Number of events 3
|
3.9%
7/181 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
10.1%
12/119 • Number of events 14
|
10.5%
19/181 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.5%
3/119 • Number of events 3
|
1.7%
3/181 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.4%
4/119 • Number of events 4
|
1.1%
2/181 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Vascular disorders
Flushing
|
1.7%
2/119 • Number of events 2
|
0.00%
0/181
|
|
Vascular disorders
Hematoma
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/119
|
2.2%
4/181 • Number of events 7
|
|
Vascular disorders
Hypertension
|
2.5%
3/119 • Number of events 3
|
3.3%
6/181 • Number of events 7
|
|
Vascular disorders
Hypotension
|
13.4%
16/119 • Number of events 17
|
12.2%
22/181 • Number of events 26
|
|
Vascular disorders
Phlebitis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
1.7%
2/119 • Number of events 2
|
7.2%
13/181 • Number of events 13
|
|
Vascular disorders
Vascular disorder
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 5
|
Other adverse events
| Measure |
Phase I - Alemtuzumab and Combination Chemotherapy
n=119 participants at risk
See detailed description or participant flow.
|
Phase II - Alemtuzumab and Combination Chemotherapy
n=181 participants at risk
See detailed description or participant flow.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.84%
1/119 • Number of events 1
|
2.8%
5/181 • Number of events 9
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/119
|
2.2%
4/181 • Number of events 4
|
|
Cardiac disorders
Cardiac pain
|
1.7%
2/119 • Number of events 2
|
3.3%
6/181 • Number of events 6
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 4
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/119
|
0.00%
0/181
|
|
Cardiac disorders
Palpitations
|
0.00%
0/119
|
1.7%
3/181 • Number of events 7
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 3
|
|
Cardiac disorders
Sinus bradycardia
|
0.84%
1/119 • Number of events 1
|
3.3%
6/181 • Number of events 7
|
|
Cardiac disorders
Sinus tachycardia
|
9.2%
11/119 • Number of events 14
|
12.7%
23/181 • Number of events 25
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
1.7%
2/119 • Number of events 4
|
1.1%
2/181 • Number of events 2
|
|
Ear and labyrinth disorders
Ear disorder
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 4
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/119
|
2.8%
5/181 • Number of events 5
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
0.84%
1/119 • Number of events 1
|
2.8%
5/181 • Number of events 11
|
|
Eye disorders
Eye disorder
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 5
|
|
Eye disorders
Eye pain
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Eye disorders
Flashing vision
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Eye disorders
Glaucoma
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Eye disorders
Optic nerve edema
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Eye disorders
Photophobia
|
2.5%
3/119 • Number of events 3
|
2.8%
5/181 • Number of events 5
|
|
Eye disorders
Vision blurred
|
2.5%
3/119 • Number of events 3
|
7.2%
13/181 • Number of events 15
|
|
Eye disorders
Vitreous hemorrhage
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Eye disorders
Watering eyes
|
1.7%
2/119 • Number of events 2
|
1.7%
3/181 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
6/119 • Number of events 6
|
2.2%
4/181 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
14/119 • Number of events 18
|
24.9%
45/181 • Number of events 57
|
|
Gastrointestinal disorders
Anal exam abnormal
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Gastrointestinal disorders
Anal pain
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
2.5%
3/119 • Number of events 3
|
1.7%
3/181 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
20.2%
24/119 • Number of events 36
|
35.4%
64/181 • Number of events 87
|
|
Gastrointestinal disorders
Diarrhea
|
39.5%
47/119 • Number of events 63
|
44.2%
80/181 • Number of events 124
|
|
Gastrointestinal disorders
Dry mouth
|
0.84%
1/119 • Number of events 1
|
4.4%
8/181 • Number of events 14
|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
1.7%
2/119 • Number of events 2
|
0.00%
0/181
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
5.9%
7/119 • Number of events 7
|
6.1%
11/181 • Number of events 11
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
46.2%
55/119 • Number of events 74
|
51.4%
93/181 • Number of events 141
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
78.2%
93/119 • Number of events 352
|
82.9%
150/181 • Number of events 650
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
1.7%
2/119 • Number of events 2
|
0.55%
1/181 • Number of events 1
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
2.5%
3/119 • Number of events 3
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
8.4%
10/119 • Number of events 14
|
16.0%
29/181 • Number of events 37
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
7/119 • Number of events 7
|
5.5%
10/181 • Number of events 10
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
18.5%
22/119 • Number of events 27
|
26.5%
48/181 • Number of events 60
|
|
Gastrointestinal disorders
Esophageal mucositis
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/119
|
4.4%
8/181 • Number of events 8
|
|
Gastrointestinal disorders
Esophagitis
|
5.0%
6/119 • Number of events 6
|
1.7%
3/181 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
0.84%
1/119 • Number of events 2
|
1.7%
3/181 • Number of events 3
|
|
Gastrointestinal disorders
Gastric mucositis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
4.2%
5/119 • Number of events 5
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.4%
4/119 • Number of events 4
|
3.9%
7/181 • Number of events 10
|
|
Gastrointestinal disorders
Gastroscopy abnormal
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Gingival pain
|
1.7%
2/119 • Number of events 2
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.5%
3/119 • Number of events 4
|
6.1%
11/181 • Number of events 11
|
|
Gastrointestinal disorders
Ileus
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
23.5%
28/119 • Number of events 37
|
16.0%
29/181 • Number of events 35
|
|
Gastrointestinal disorders
Nausea
|
49.6%
59/119 • Number of events 112
|
66.9%
121/181 • Number of events 287
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
0.00%
0/119
|
2.2%
4/181 • Number of events 4
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
3.4%
4/119 • Number of events 4
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis
|
0.84%
1/119 • Number of events 1
|
3.9%
7/181 • Number of events 7
|
|
Gastrointestinal disorders
Peritoneal pain
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Proctitis
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.84%
1/119 • Number of events 1
|
2.8%
5/181 • Number of events 5
|
|
Gastrointestinal disorders
Rectal pain
|
2.5%
3/119 • Number of events 3
|
5.0%
9/181 • Number of events 10
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
0.84%
1/119 • Number of events 1
|
2.8%
5/181 • Number of events 6
|
|
Gastrointestinal disorders
Tooth disorder
|
1.7%
2/119 • Number of events 2
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
3.4%
4/119 • Number of events 4
|
2.2%
4/181 • Number of events 4
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
26.9%
32/119 • Number of events 54
|
43.1%
78/181 • Number of events 142
|
|
General disorders
Chest pain
|
3.4%
4/119 • Number of events 5
|
5.0%
9/181 • Number of events 10
|
|
General disorders
Chills
|
16.0%
19/119 • Number of events 20
|
25.4%
46/181 • Number of events 65
|
|
General disorders
Death NOS
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
General disorders
Edema limbs
|
14.3%
17/119 • Number of events 27
|
27.1%
49/181 • Number of events 78
|
|
General disorders
Facial pain
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
General disorders
Fatigue
|
53.8%
64/119 • Number of events 154
|
64.1%
116/181 • Number of events 272
|
|
General disorders
Fever
|
15.1%
18/119 • Number of events 19
|
28.2%
51/181 • Number of events 76
|
|
General disorders
Flu-like symptoms
|
0.84%
1/119 • Number of events 2
|
0.55%
1/181 • Number of events 1
|
|
General disorders
Gait abnormal
|
1.7%
2/119 • Number of events 2
|
0.55%
1/181 • Number of events 1
|
|
General disorders
General symptom
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 6
|
|
General disorders
Hypothermia
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
General disorders
Ill-defined disorder
|
0.00%
0/119
|
1.7%
3/181 • Number of events 6
|
|
General disorders
Injection site reaction
|
16.0%
19/119 • Number of events 21
|
11.6%
21/181 • Number of events 28
|
|
General disorders
Localized edema
|
4.2%
5/119 • Number of events 5
|
5.5%
10/181 • Number of events 10
|
|
General disorders
Pain
|
14.3%
17/119 • Number of events 19
|
11.0%
20/181 • Number of events 22
|
|
General disorders
Visceral edema
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Immune system disorders
Hypersensitivity
|
5.0%
6/119 • Number of events 7
|
5.5%
10/181 • Number of events 10
|
|
Immune system disorders
Immune system disorder
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Infections and infestations
Abdominal infection
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Infections and infestations
Anal infection
|
1.7%
2/119 • Number of events 2
|
2.8%
5/181 • Number of events 6
|
|
Infections and infestations
Anorectal infection
|
1.7%
2/119 • Number of events 3
|
4.4%
8/181 • Number of events 11
|
|
Infections and infestations
Bladder infection
|
2.5%
3/119 • Number of events 3
|
2.2%
4/181 • Number of events 4
|
|
Infections and infestations
Bronchitis
|
1.7%
2/119 • Number of events 2
|
1.7%
3/181 • Number of events 3
|
|
Infections and infestations
Catheter related infection
|
13.4%
16/119 • Number of events 20
|
9.9%
18/181 • Number of events 21
|
|
Infections and infestations
Conjunctivitis infective
|
2.5%
3/119 • Number of events 3
|
1.1%
2/181 • Number of events 2
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Infections and infestations
Eye infection
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Infections and infestations
Gingival infection
|
2.5%
3/119 • Number of events 3
|
3.9%
7/181 • Number of events 7
|
|
Infections and infestations
Ileal infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 2
|
|
Infections and infestations
Infection
|
10.9%
13/119 • Number of events 15
|
8.8%
16/181 • Number of events 20
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
1.7%
2/119 • Number of events 2
|
0.00%
0/181
|
|
Infections and infestations
Infection without neutropenia
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Infections and infestations
Infectious colitis
|
3.4%
4/119 • Number of events 5
|
3.9%
7/181 • Number of events 8
|
|
Infections and infestations
Laryngitis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Lip infection
|
3.4%
4/119 • Number of events 5
|
1.7%
3/181 • Number of events 4
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Nail infection
|
0.84%
1/119 • Number of events 2
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Opportunistic infection
|
1.7%
2/119 • Number of events 5
|
1.7%
3/181 • Number of events 3
|
|
Infections and infestations
Otitis externa
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Infections and infestations
Otitis media
|
1.7%
2/119 • Number of events 2
|
1.7%
3/181 • Number of events 3
|
|
Infections and infestations
Paranasal sinus infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Penile infection
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 3
|
|
Infections and infestations
Peripheral nerve infection
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Infections and infestations
Phlebitis infective
|
0.84%
1/119 • Number of events 3
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
8.4%
10/119 • Number of events 12
|
8.8%
16/181 • Number of events 20
|
|
Infections and infestations
Rhinitis infective
|
1.7%
2/119 • Number of events 2
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Salivary gland infection
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Sepsis
|
23.5%
28/119 • Number of events 39
|
29.8%
54/181 • Number of events 64
|
|
Infections and infestations
Sinusitis
|
8.4%
10/119 • Number of events 10
|
8.8%
16/181 • Number of events 27
|
|
Infections and infestations
Skin infection
|
5.0%
6/119 • Number of events 8
|
11.0%
20/181 • Number of events 23
|
|
Infections and infestations
Small intestine infection
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Infections and infestations
Soft tissue infection
|
1.7%
2/119 • Number of events 2
|
3.3%
6/181 • Number of events 7
|
|
Infections and infestations
Tooth infection
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Tracheitis
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Infections and infestations
Upper respiratory infection
|
8.4%
10/119 • Number of events 13
|
7.7%
14/181 • Number of events 17
|
|
Infections and infestations
Ureteritis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Urethral infection
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
3.4%
4/119 • Number of events 9
|
7.2%
13/181 • Number of events 17
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/119
|
0.55%
1/181 • Number of events 2
|
|
Infections and infestations
Viral hepatitis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Wound infection
|
4.2%
5/119 • Number of events 5
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Bruising
|
0.84%
1/119 • Number of events 1
|
2.8%
5/181 • Number of events 7
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/119
|
1.1%
2/181 • Number of events 3
|
|
Injury, poisoning and procedural complications
Intraoperative hepatobiliary injury - Gallbladder
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intraoperative venous injury - Vein-superior vena cava
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Injury, poisoning and procedural complications
Prolapse of intestinal stoma
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.7%
2/119 • Number of events 2
|
3.3%
6/181 • Number of events 6
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Investigations
ADH abnormal
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.2%
24/119 • Number of events 38
|
21.5%
39/181 • Number of events 64
|
|
Investigations
Alanine aminotransferase increased
|
55.5%
66/119 • Number of events 180
|
67.4%
122/181 • Number of events 328
|
|
Investigations
Alkaline phosphatase
|
0.84%
1/119 • Number of events 2
|
0.00%
0/181
|
|
Investigations
Alkaline phosphatase increased
|
34.5%
41/119 • Number of events 68
|
51.4%
93/181 • Number of events 163
|
|
Investigations
Amylase increased
|
3.4%
4/119 • Number of events 4
|
5.0%
9/181 • Number of events 12
|
|
Investigations
Aspartate aminotransferase increased
|
49.6%
59/119 • Number of events 137
|
59.7%
108/181 • Number of events 266
|
|
Investigations
Blood bilirubin increased
|
56.3%
67/119 • Number of events 131
|
55.8%
101/181 • Number of events 174
|
|
Investigations
Blood gonadotrophin abnormal
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/119
|
1.1%
2/181 • Number of events 5
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Investigations
Coagulopathy
|
5.9%
7/119 • Number of events 7
|
4.4%
8/181 • Number of events 18
|
|
Investigations
Creatinine increased
|
17.6%
21/119 • Number of events 30
|
22.1%
40/181 • Number of events 70
|
|
Investigations
Fibrinogen decreased
|
47.9%
57/119 • Number of events 66
|
51.4%
93/181 • Number of events 118
|
|
Investigations
Forced expiratory volume decreased
|
0.84%
1/119 • Number of events 2
|
0.00%
0/181
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.0%
6/119 • Number of events 7
|
1.7%
3/181 • Number of events 10
|
|
Investigations
INR increased
|
6.7%
8/119 • Number of events 10
|
13.8%
25/181 • Number of events 48
|
|
Investigations
Laboratory test abnormal
|
6.7%
8/119 • Number of events 10
|
5.0%
9/181 • Number of events 36
|
|
Investigations
Leukocyte count decreased
|
16.0%
19/119 • Number of events 45
|
23.8%
43/181 • Number of events 123
|
|
Investigations
Lipase increased
|
0.00%
0/119
|
5.0%
9/181 • Number of events 10
|
|
Investigations
Lymphocyte count decreased
|
14.3%
17/119 • Number of events 36
|
16.6%
30/181 • Number of events 65
|
|
Investigations
Neutrophil count decreased
|
79.8%
95/119 • Number of events 312
|
81.2%
147/181 • Number of events 575
|
|
Investigations
Platelet count decreased
|
78.2%
93/119 • Number of events 306
|
82.3%
149/181 • Number of events 594
|
|
Investigations
Serum cholesterol increased
|
2.5%
3/119 • Number of events 3
|
1.1%
2/181 • Number of events 2
|
|
Investigations
Vital capacity decreased
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Investigations
Weight gain
|
4.2%
5/119 • Number of events 7
|
2.8%
5/181 • Number of events 6
|
|
Investigations
Weight loss
|
8.4%
10/119 • Number of events 11
|
11.0%
20/181 • Number of events 21
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Metabolism and nutrition disorders
Anorexia
|
16.8%
20/119 • Number of events 27
|
29.8%
54/181 • Number of events 80
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
1.7%
2/119 • Number of events 2
|
1.1%
2/181 • Number of events 2
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
76.5%
91/119 • Number of events 281
|
75.7%
137/181 • Number of events 426
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
7.6%
9/119 • Number of events 10
|
8.3%
15/181 • Number of events 25
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
3/119 • Number of events 4
|
5.0%
9/181 • Number of events 10
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
45.4%
54/119 • Number of events 99
|
43.6%
79/181 • Number of events 170
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
52.1%
62/119 • Number of events 106
|
53.6%
97/181 • Number of events 204
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
2.5%
3/119 • Number of events 10
|
3.9%
7/181 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
6.7%
8/119 • Number of events 11
|
11.0%
20/181 • Number of events 34
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
14.3%
17/119 • Number of events 26
|
23.8%
43/181 • Number of events 74
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
12.6%
15/119 • Number of events 15
|
16.0%
29/181 • Number of events 35
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
16.0%
19/119 • Number of events 28
|
21.5%
39/181 • Number of events 47
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
33.6%
40/119 • Number of events 78
|
49.2%
89/181 • Number of events 184
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
6.7%
8/119 • Number of events 9
|
11.6%
21/181 • Number of events 21
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
32.8%
39/119 • Number of events 68
|
46.4%
84/181 • Number of events 161
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
4.2%
5/119 • Number of events 6
|
4.4%
8/181 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
4.2%
5/119 • Number of events 5
|
2.2%
4/181 • Number of events 5
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
4.2%
5/119 • Number of events 5
|
3.9%
7/181 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.4%
10/119 • Number of events 12
|
13.8%
25/181 • Number of events 33
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.9%
13/119 • Number of events 18
|
30.4%
55/181 • Number of events 79
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.2%
11/119 • Number of events 13
|
12.2%
22/181 • Number of events 27
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.5%
3/119 • Number of events 4
|
6.6%
12/181 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased lumbar spine
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.9%
7/119 • Number of events 9
|
8.3%
15/181 • Number of events 32
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.7%
2/119 • Number of events 2
|
3.3%
6/181 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.1%
12/119 • Number of events 15
|
14.4%
26/181 • Number of events 36
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.84%
1/119 • Number of events 1
|
6.1%
11/181 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
8/119 • Number of events 9
|
14.4%
26/181 • Number of events 38
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/119
|
1.7%
3/181 • Number of events 3
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.84%
1/119 • Number of events 6
|
0.00%
0/181
|
|
Nervous system disorders
Ataxia
|
5.0%
6/119 • Number of events 6
|
3.9%
7/181 • Number of events 10
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
1.7%
2/119 • Number of events 3
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
1.7%
2/119 • Number of events 2
|
1.1%
2/181 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
16.0%
19/119 • Number of events 27
|
21.0%
38/181 • Number of events 51
|
|
Nervous system disorders
Dysgeusia
|
6.7%
8/119 • Number of events 9
|
6.1%
11/181 • Number of events 12
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 3
|
|
Nervous system disorders
Facial nerve disorder
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Nervous system disorders
Headache
|
32.8%
39/119 • Number of events 66
|
48.6%
88/181 • Number of events 181
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/119
|
1.7%
3/181 • Number of events 3
|
|
Nervous system disorders
Mini mental status examination abnormal
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Myelitis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/119
|
4.4%
8/181 • Number of events 8
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/119
|
4.4%
8/181 • Number of events 10
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.1%
12/119 • Number of events 17
|
7.7%
14/181 • Number of events 22
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
43.7%
52/119 • Number of events 129
|
45.9%
83/181 • Number of events 194
|
|
Nervous system disorders
Seizure
|
0.00%
0/119
|
0.55%
1/181 • Number of events 2
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Nervous system disorders
Speech disorder
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Nervous system disorders
Syncope
|
2.5%
3/119 • Number of events 4
|
0.00%
0/181
|
|
Nervous system disorders
Tremor
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
1.7%
2/119 • Number of events 3
|
1.1%
2/181 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
16.0%
19/119 • Number of events 24
|
11.6%
21/181 • Number of events 44
|
|
Psychiatric disorders
Confusion
|
4.2%
5/119 • Number of events 5
|
4.4%
8/181 • Number of events 8
|
|
Psychiatric disorders
Depression
|
16.8%
20/119 • Number of events 22
|
14.4%
26/181 • Number of events 46
|
|
Psychiatric disorders
Insomnia
|
12.6%
15/119 • Number of events 27
|
17.1%
31/181 • Number of events 48
|
|
Psychiatric disorders
Libido decreased
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Psychiatric disorders
Personality change
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/119
|
2.8%
5/181 • Number of events 5
|
|
Renal and urinary disorders
Bladder hemorrhage
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/119
|
1.7%
3/181 • Number of events 7
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/119
|
1.7%
3/181 • Number of events 3
|
|
Renal and urinary disorders
Proteinuria
|
1.7%
2/119 • Number of events 2
|
2.2%
4/181 • Number of events 6
|
|
Renal and urinary disorders
Renal failure
|
2.5%
3/119 • Number of events 3
|
3.3%
6/181 • Number of events 9
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
4.2%
5/119 • Number of events 5
|
7.2%
13/181 • Number of events 14
|
|
Renal and urinary disorders
Urinary incontinence
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
2/119 • Number of events 2
|
1.1%
2/181 • Number of events 2
|
|
Renal and urinary disorders
Urine discoloration
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Renal and urinary disorders
Urogenital disorder
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 4
|
|
Reproductive system and breast disorders
Breast pain
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/119
|
1.1%
2/181 • Number of events 3
|
|
Reproductive system and breast disorders
Feminization
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Reproductive system and breast disorders
Ovulation pain
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/119
|
1.7%
3/181 • Number of events 3
|
|
Reproductive system and breast disorders
Testicular pain
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
3.4%
4/119 • Number of events 4
|
2.2%
4/181 • Number of events 5
|
|
Reproductive system and breast disorders
Vaginal mucositis
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.7%
2/119 • Number of events 2
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
6/119 • Number of events 7
|
7.7%
14/181 • Number of events 24
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.7%
2/119 • Number of events 3
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hemorrhage
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/119
|
1.7%
3/181 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.5%
3/119 • Number of events 4
|
1.7%
3/181 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.8%
20/119 • Number of events 28
|
30.4%
55/181 • Number of events 102
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.6%
21/119 • Number of events 37
|
26.5%
48/181 • Number of events 74
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.6%
9/119 • Number of events 11
|
7.2%
13/181 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.2%
5/119 • Number of events 5
|
5.5%
10/181 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.2%
5/119 • Number of events 5
|
5.0%
9/181 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Laryngoscopy abnormal
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/119
|
1.7%
3/181 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.84%
1/119 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.2%
5/119 • Number of events 5
|
9.9%
18/181 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
6/119 • Number of events 6
|
6.1%
11/181 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/119
|
1.7%
3/181 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
3/119 • Number of events 3
|
2.2%
4/181 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.84%
1/119 • Number of events 1
|
5.0%
9/181 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.00%
0/119
|
0.55%
1/181 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tracheoscopy abnormal
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.5%
3/119 • Number of events 3
|
1.1%
2/181 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.2%
24/119 • Number of events 49
|
18.2%
33/181 • Number of events 57
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/119
|
1.1%
2/181 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.7%
2/119 • Number of events 2
|
3.9%
7/181 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.84%
1/119 • Number of events 1
|
0.00%
0/181
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.84%
1/119 • Number of events 1
|
0.55%
1/181 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.7%
8/119 • Number of events 9
|
8.3%
15/181 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.84%
1/119 • Number of events 2
|
1.7%
3/181 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
5/119 • Number of events 6
|
12.7%
23/181 • Number of events 26
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.4%
4/119 • Number of events 5
|
1.7%
3/181 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
24.4%
29/119 • Number of events 37
|
35.9%
65/181 • Number of events 97
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.7%
2/119 • Number of events 2
|
6.6%
12/181 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/119
|
1.1%
2/181 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.84%
1/119 • Number of events 1
|
1.7%
3/181 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Sweating
|
7.6%
9/119 • Number of events 10
|
17.1%
31/181 • Number of events 36
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.84%
1/119 • Number of events 1
|
3.3%
6/181 • Number of events 7
|
|
Vascular disorders
Flushing
|
1.7%
2/119 • Number of events 2
|
1.7%
3/181 • Number of events 3
|
|
Vascular disorders
Hematoma
|
0.84%
1/119 • Number of events 1
|
2.2%
4/181 • Number of events 4
|
|
Vascular disorders
Hemorrhage
|
1.7%
2/119 • Number of events 2
|
5.0%
9/181 • Number of events 9
|
|
Vascular disorders
Hot flashes
|
2.5%
3/119 • Number of events 7
|
1.1%
2/181 • Number of events 8
|
|
Vascular disorders
Hypertension
|
7.6%
9/119 • Number of events 10
|
6.6%
12/181 • Number of events 15
|
|
Vascular disorders
Hypotension
|
11.8%
14/119 • Number of events 15
|
19.3%
35/181 • Number of events 37
|
|
Vascular disorders
Phlebitis
|
2.5%
3/119 • Number of events 3
|
2.2%
4/181 • Number of events 4
|
|
Vascular disorders
Thrombosis
|
3.4%
4/119 • Number of events 4
|
6.1%
11/181 • Number of events 11
|
|
Vascular disorders
Vascular disorder
|
0.00%
0/119
|
0.55%
1/181 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60