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NCT00980460 · ADVERSE EVENTS

Adverse events

Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer · Source last updated 2026-06-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
AEs and OAEs: Up to 6 months post-treatment planned as 18 months; All-Cause Mortality: up to 10 years
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Very Low-risk Group

Patients undergo surgery and then receive no further treatment. Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery

0 / 80 / 80 / 8
Low-risk Group (Regimen T)

Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV

0 / 4924 / 493 / 49
Intermediate-risk Group (Regimen F)

Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012) Cisplatin: Given IV Dexrazoxane: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV

3 / 10291 / 1027 / 102
High-risk Group (Regimen W)

(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV

2 / 3127 / 3111 / 31
High-risk Group (Regimen H)

Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Temsirolimus: Given IV Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV

1 / 3632 / 3613 / 36

Group identifiers: EG000: Very Low-risk Group · EG001: Low-risk Group (Regimen T) · EG002: Intermediate-risk Group (Regimen F) · EG003: High-risk Group (Regimen W) · EG004: High-risk Group (Regimen H)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Ascites
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Cardiac disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Disseminated intravascular coagulation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Esophageal hemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Heart failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Hypoxia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Abdominal infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      36
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Abducens nerve disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
    term
    Acidosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
    term
    Activated partial thromboplastin time prolonged
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Agitation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      36
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
    term
    Alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
    term
    Alkalosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
    term
    Allergic reaction
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    Patients undergo surgery and then receive no further treatment. Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
    id
    EG000
    other Num Affected
    0
    other Num At Risk
    8
    serious Num Affected
    0
    serious Num At Risk
    8
    title
    Very Low-risk Group
  2. deaths Num Affected
    3
    deaths Num At Risk
    49
    description
    Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV
    id
    EG001
    other Num Affected
    24
    other Num At Risk
    49
    serious Num Affected
    0
    serious Num At Risk
    49
    title
    Low-risk Group (Regimen T)
  3. deaths Num Affected
    7
    deaths Num At Risk
    102
    description
    Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012) Cisplatin: Given IV Dexrazoxane: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV
    id
    EG002
    other Num Affected
    91
    other Num At Risk
    102
    serious Num Affected
    3
    serious Num At Risk
    102
    title
    Intermediate-risk Group (Regimen F)
  4. deaths Num Affected
    11
    deaths Num At Risk
    31
    description
    (regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV
    id
    EG003
    other Num Affected
    27
    other Num At Risk
    31
    serious Num Affected
    2
    serious Num At Risk
    31
    title
    High-risk Group (Regimen W)
  5. deaths Num Affected
    13
    deaths Num At Risk
    36
    description
    Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Temsirolimus: Given IV Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV
    id
    EG004
    other Num Affected
    32
    other Num At Risk
    36
    serious Num Affected
    1
    serious Num At Risk
    36
    title
    High-risk Group (Regimen H)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Abdominal infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      36
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Abducens nerve disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
    term
    Acidosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
    term
    Activated partial thromboplastin time prolonged
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Agitation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      36
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
    term
    Alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
    term
    Alkalosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
    term
    Allergic reaction
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Ascites
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Cardiac disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Disseminated intravascular coagulation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Esophageal hemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Heart failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
    term
    Hypoxia
time Frame
AEs and OAEs: Up to 6 months post-treatment planned as 18 months; All-Cause Mortality: up to 10 years

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Preserved source evidence · Not medical advice